🕷️ Crawler Inspector

URL Lookup

Direct Parameter Lookup

Raw Queries and Responses

1. Shard Calculation

Query:

Response:

Calculated Shard: 133 (from laksa123)

2. Crawled Status Check

Query:

curl -X POST \
  'http://laksa133.int.ahrefs:8124/' \
  -H 'Content-Type: text/plain' \
  -H 'X-ClickHouse-Database: crawler3' \
  -H 'Authorization: Basic YXBpOg==' \
  -d 'SELECT getAhrefsURLFromUnparsed(src_unparsed) AS found_url, ifNull(toUnixTimestamp(download_stamp), 0) AS crawl_time, ifNull(toUnixTimestamp(props_url_first_seen), 0) AS first_indexed_time, download_http_code AS http_code, src_unparsed AS src_unparsed, src_root_hash AS src_root_hash, history_drop_reason AS history_drop_reason, meta_title AS meta_title, meta_descriptions AS meta_descriptions, attrs_boilerpipe_text AS attrs_boilerpipe_text, attrs_markdown AS attrs_markdown, attrs_readable_markdown AS attrs_readable_markdown, meta_canonical AS meta_canonical FROM crawler3.page_info_local FINAL PREWHERE (src_root_hash, src_unparsed) IN ((getAhrefsRootHashFromUnparsed(getAhrefsUnparsedNoserviceFromURL(\'https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs\')), getAhrefsUnparsedNoserviceFromURL(\'https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs\'))) FORMAT JSONEachRow'

Response:

{"found_url":"https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs","crawl_time":1775937182,"first_indexed_time":0,"http_code":200,"src_unparsed":"gov,fda!www,\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs s443","src_root_hash":"14166993592195710533","history_drop_reason":null,"meta_title":"Coronavirus (COVID-19) | Drugs | FDA","meta_descriptions":["CDER is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic."],"attrs_boilerpipe_text":"When FDA approves a drug, it means the agency has determined, among other things, that:\nThe drug is safe and effective for its intended use;\nThe benefits of the drug outweigh its risks when used according to its approved labeling;\nThe drug’s labeling (including the package insert) is appropriate; and\nThe methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity.\nThe statutory standard for an FDA-approval requires substantial evidence of effectiveness, which is a different level of evidence of effectiveness than required for an EUA.\nUnder section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services (HHS), authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, among other things, that:\nBased on the totality of scientific evidence available-\nThe product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent;\nThat the known and potential benefits of the product, when used to diagnose, prevent or treat such disease or condition, outweigh the known and potential risks of the product; and\nThat there are no adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such disease or condition.\nFDA may\nrevise or revoke\nEUAs at any time, for example, when the drug receives FDA-approval and such product is sufficiently available to meet the public health demand, or when revision or revocation is appropriate to protect the public health or safety.\nFDA’s\nEUA page\nhas information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product fact sheets and additional information for health care professionals and patients. FDA and Health and Human Services Administration for Strategic Preparedness and\nResponse\nhave announced extensions to the shelf life for some EUA products. Find these updates on FDA’s\nExpiration Dating Extension\npage.\nLearn more about EUAs in\nthis video\n.\nRead more about COVID-19 regulatory terminology on the\nFDA website\n.","attrs_markdown":"- [Skip to main content](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#main-content)\n- [Skip to FDA Search](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#search-form)\n- [Skip to in this section menu](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#section-nav)\n- [Skip to footer links](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#footer)\n\n![U.S. flag](https:\/\/www.fda.gov\/themes\/custom\/preview\/assets\/images\/US_Flag.png) An official website of the United States government [Here’s how you know](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs)\n\n![Dot gov](https:\/\/www.fda.gov\/themes\/custom\/preview\/assets\/images\/icon-dot-gov.svg)\n\n**The .gov means it’s official.**  \nFederal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.\n\n![SSL](https:\/\/www.fda.gov\/themes\/custom\/preview\/assets\/images\/icon-https.svg)\n\n**The site is secure.**  \n The **https:\/\/** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.\n\n[![U.S. Food and Drug Administration logo](https:\/\/www.fda.gov\/themes\/custom\/preview\/assets\/images\/FDA_Logo_Icon_White.svg)](https:\/\/www.fda.gov\/ \"FDA Homepage\")\n\n- Search\n- Menu\n\n## Featured\n- [Report a Product Problem](https:\/\/www.safetyreporting.hhs.gov\/smarthub#\/ \"Report a Problem with an FDA Regulated Product\")\n- [Contact FDA](https:\/\/www.fda.gov\/about-fda\/contact-fda)\n- [FDA Guidance Documents](https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents)\n- [Recalls, Market Withdrawals and Safety Alerts](https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts)\n- [Press Announcements](https:\/\/www.fda.gov\/news-events\/newsroom\/press-announcements)\n- [Warning Letters](https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-actions-and-activities\/warning-letters)\n- [Advisory Committees](https:\/\/www.fda.gov\/advisory-committees)\n- [En Espa\\&\\#241ol](https:\/\/www.fda.gov\/fda-en-espanol)\n\n## Products\n- [Food](https:\/\/www.fda.gov\/food)\n- [Drugs](https:\/\/www.fda.gov\/drugs)\n- [Medical Devices](https:\/\/www.fda.gov\/medical-devices)\n- [Radiation-Emitting Products](https:\/\/www.fda.gov\/radiation-emitting-products)\n- [Vaccines, Blood, and Biologics](https:\/\/www.fda.gov\/vaccines-blood-biologics)\n- [Animal and Veterinary](https:\/\/www.fda.gov\/animal-veterinary)\n- [Cosmetics](https:\/\/www.fda.gov\/cosmetics)\n- [Tobacco Products](https:\/\/www.fda.gov\/tobacco-products)\n\n## Topics\n- [About FDA](https:\/\/www.fda.gov\/about-fda)\n- [Combination Products](https:\/\/www.fda.gov\/combination-products)\n- [Regulatory Information](https:\/\/www.fda.gov\/regulatory-information)\n- [Safety](https:\/\/www.fda.gov\/safety)\n- [Emergency Preparedness](https:\/\/www.fda.gov\/emergency-preparedness-and-response)\n- [International Programs](https:\/\/www.fda.gov\/international-programs)\n- [News and Events](https:\/\/www.fda.gov\/news-events)\n- [Training and Continuing Education](https:\/\/www.fda.gov\/training-and-continuing-education)\n- [Inspections and Compliance](https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations)\n- [Science and Research](https:\/\/www.fda.gov\/science-research)\n\n## Information For\n- [Consumers](https:\/\/www.fda.gov\/consumers)\n- [Patients](https:\/\/www.fda.gov\/patients)\n- [Industry](https:\/\/www.fda.gov\/industry)\n- [Health Professionals](https:\/\/www.fda.gov\/health-professionals)\n- [Federal, State and Local Officials](https:\/\/www.fda.gov\/federal-state-local-tribal-and-territorial-officials)\n\n[In this section: Emergency Preparedness \\| Drugs](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#section-nav)\n\n- [Coronavirus (COVID-19) \\| Drugs](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs)\n  - [Coronavirus Treatment Acceleration Program (CTAP)](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/coronavirus-treatment-acceleration-program-ctap)\n  - [CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products \\| COVID-19](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological)\n\n1. [Home](https:\/\/www.fda.gov\/)\n2. [Drugs](https:\/\/www.fda.gov\/drugs)\n3. [Emergency Preparedness \\| Drugs](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs)\n4. [Coronavirus (COVID-19) \\| Drugs]()\n\n1. [Emergency Preparedness \\| Drugs](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs \"Emergency Preparedness | Drugs\")\n\n# Coronavirus (COVID-19) \\| Drugs\n- [Coronavirus (COVID-19) \\| Drugs](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs)\n  - [Coronavirus Treatment Acceleration Program (CTAP)](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/coronavirus-treatment-acceleration-program-ctap)\n  - [CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products \\| COVID-19](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological)\n\n[Español](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/coronavirus-covid-19-medicamentos \"Coronavirus (COVID-19) | Medicamentos\")\n\nIn response to the novel coronavirus (COVID-19), FDA quickly created, in March 2020, the Coronavirus Treatment Acceleration Program (CTAP), which was designed to help facilitate the development of drugs and biological products (other than vaccines) for COVID-19 therapeutics. The development of COVID-19 therapeutics that are effective against current and future variants remains a critical priority. CTAP is leveraging the agency’s scientific experience and knowledge of COVID-19 to support current and future clinical trials testing new treatments for COVID-19. From these efforts, we continue to gain valuable knowledge about the safety and effectiveness of potential therapies for COVID-19.\n\n## COVID-19 Therapeutics\n## [What is the difference between FDA approved drugs and drugs authorized under an emergency use authorization (EUA)?](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#69da86e870310)\nWhen FDA approves a drug, it means the agency has determined, among other things, that:\n\n- The drug is safe and effective for its intended use;\n- The benefits of the drug outweigh its risks when used according to its approved labeling;\n- The drug’s labeling (including the package insert) is appropriate; and\n- The methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity.\n\nThe statutory standard for an FDA-approval requires substantial evidence of effectiveness, which is a different level of evidence of effectiveness than required for an EUA.\n\nUnder section 564 of the Federal Food, Drug & Cosmetic Act (FD\\&C Act), FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services (HHS), authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, among other things, that:\n\n- Based on the totality of scientific evidence available-\n  - The product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent;\n  - That the known and potential benefits of the product, when used to diagnose, prevent or treat such disease or condition, outweigh the known and potential risks of the product; and\n- That there are no adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such disease or condition.\n\nFDA may [revise or revoke](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/faqs-what-happens-euas-when-public-health-emergency-ends \"FAQs: What happens to EUAs when a public health emergency ends?\") EUAs at any time, for example, when the drug receives FDA-approval and such product is sufficiently available to meet the public health demand, or when revision or revocation is appropriate to protect the public health or safety.\n\nFDA’s [EUA page](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/emergency-use-authorization \"Emergency Use Authorization\") has information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product fact sheets and additional information for health care professionals and patients. FDA and Health and Human Services Administration for Strategic Preparedness and [Response](https:\/\/aspr.hhs.gov\/Pages\/Home.aspx) have announced extensions to the shelf life for some EUA products. Find these updates on FDA’s [Expiration Dating Extension](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/expiration-dating-extension \"Expiration Dating Extension\") page.\n\nLearn more about EUAs in [this video](https:\/\/www.youtube.com\/watch?v=iGkwaESsGBQ).  \n Read more about COVID-19 regulatory terminology on the [FDA website](https:\/\/www.fda.gov\/node\/393224).\n\n## [Types of Treatments (Approved or under EUA)](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#69da86e870c2a)\n- **Antiviral Drugs**  \n   Antiviral drugs are medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against viruses in your body.\n- **Immune Modulators**  \n   Immune modulators are medicines that help activate, boost, or suppress the immune function. In the case of COVID-19 infection, the immune system can become hyperactive which may result in worsening of disease. Immune modulators can help suppress this hyperinflammation.\n- **Monoclonal Antibodies (mAbs) targeting SARS-COV-2**  \n   SARS-COV-2-targeting mAbs are laboratory-produced antibodies that can help the immune system's attack on SARS-COV-2. These mAbs block entry of SARS-CoV-2 into human cells, thus neutralizing the virus. SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains. Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19.\n- **Renal Replacement Therapy Solutions**  \n   Continuous renal replacement therapy (CRRT) is a type of “dialysis,” which is a machine treatment that filters and purifies the blood when a patient’s kidneys are damaged or are not functioning normally. CRRT is used for patients with kidney injury in acute care settings. SARS-CoV-2 led to an increased population with critical illness and multiple organ failure, including acute kidney injury, increasing the need for CRRT. In addition, there was an insufficient supply of replacement solutions to meet the emergency need to provide CRRT in critically ill patients.\n\n## [FDA Approved or Authorized Drugs to Reduce the Risk of Hospitalization or Death for Patients with Mild to Moderate COVID-19](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#69da86e870cb3)\n- [Paxlovid (nirmatrelvir and ritonavir)](https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/217188s000lbl.pdf) is an antiviral drug, approved for certain adults and authorized under EUA for adolescents\n- [Veklury (remdesivir)](https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/214787s024lbl.pdf) in an antiviral drug, approved for certain adults and children\n- [Lagevrio (molnupiravir)](https:\/\/www.fda.gov\/media\/155053\/download?attachment) is an antiviral drug, authorized under EUA for certain adults\n\n## [FDA Approved or Authorized Drugs or Renal Replacement Therapy Solutions to Treat or Support Patients Hospitalized Due to COVID-19](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#69da86e870d23)\n- [Actemra (tocilizumab)](https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/125276s138lbl.pdf) is an immune modulator drug, approved for certain adults, authorized under EUA for certain children\n- [Olumiant (baricitinib)](https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/207924s007lbl.pdf) is an immune modulator drug, approved for certain adults, authorized under EUA for certain children\n- [Veklury (remdesivir)](https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/214787Orig1s000lbl.pdf) is an antiviral drug, approved for certain adults and certain infants and children)\n- [Kineret (anakinra)](https:\/\/www.fda.gov\/media\/163081\/download?attachment \"Kineret LOA 11082022\") is an immune modulator drug, authorized under EUA for certain adults\n- [Gohibic (vilobelimab)](https:\/\/www.fda.gov\/media\/166823\/download?attachment \"Gohibic Emergency Use Authorization\") is an immune modulator drug, authorized under EUA for certain adults\n- [Regiocit replacement solution](https:\/\/www.fda.gov\/media\/141168\/download?attachment \"REVOKED_Regiocit EUA Letter of Authorization\") is a renal replacement therapy solution, authorized under EUA for certain adults\n- [Fresenius Medical multiFiltrate\/multiBic\/multiPlus replacement solutions](https:\/\/www.fda.gov\/media\/137520\/download?attachment \"REVOKED_Fresenius Medical, multiFiltrate PRO System and multiBic\/multiPlus Solutions - Letter of Authorization\") are renal replacement therapy solutions, authorized under EUA for certain adults\n\n## [Other Resources](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs#69da86e870da1)\n- [Know Your Treatment Options for COVID-19](https:\/\/www.fda.gov\/consumers\/consumer-updates\/know-your-treatment-options-covid-19 \"Know Your Treatment Options for COVID-19\")\n- [Emergency Use Authorizations for Drugs](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/emergency-use-authorizations-drugs-and-non-vaccine-biological-products \"Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products\")\n- [CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products \\| COVID-19](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological \"CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19\")\n- [COVID-19 Therapeutics Expiration Dating Extensions](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/expiration-dating-extension#COVIDtherapeutics \"Expiration Dating Extension\")\n- [Coronavirus Treatment Acceleration Program (CTAP)](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/coronavirus-treatment-acceleration-program-ctap \"Coronavirus Treatment Acceleration Program (CTAP)\")\n- [Revoked EUAs for COVID-19](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/emergency-use-authorization-archived-information#covid19 \"Emergency Use Authorization--Archived Information\")\n- [Coronavirus (COVID-19) \\| CBER-Regulated Biologics](https:\/\/www.fda.gov\/vaccines-blood-biologics\/industry-biologics\/coronavirus-covid-19-cber-regulated-biologics \"Coronavirus (COVID-19) | CBER-Regulated Biologics\")\n- [At-Home OTC COVID-19 Diagnostic Tests](https:\/\/www.fda.gov\/medical-devices\/coronavirus-covid-19-and-medical-devices\/home-otc-covid-19-diagnostic-tests \"At-Home OTC COVID-19 Diagnostic Tests\")\n- [FDA Coronavirus Disease 2019 (COVID-19)](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-issues\/coronavirus-disease-2019-covid-19 \"Coronavirus Disease 2019 (COVID-19)\")\n- [What Happens to EUAs when a public health emergency ends?](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/faqs-what-happens-euas-when-public-health-emergency-ends \"FAQs: What happens to EUAs when a public health emergency ends?\")\n- [USG COVID-19 Home Page](https:\/\/www.covid.gov\/)\n\nSub-Topic Paragraphs\n\n## Additional Resources\n### [Coronavirus Treatment Acceleration Program (CTAP)](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/coronavirus-treatment-acceleration-program-ctap)\nAcceleration of development for COVID-19 treatments\n\n## Additional Resources\n### [COVID-19 Treatment Hub](https:\/\/reaganudall.org\/covid-19)\nProvides physicians, patients, and caregivers with information about the latest research in the fight against COVID-19\n\n### [COVID-19 Test to Treat Locator](https:\/\/aspr.hhs.gov\/testtotreat\/Pages\/default.aspx)\nFaster, Easier Access to Life‑Saving COVID‑19 Treatments\n\n### [COVID-19 Real World Data (RWD) Data Elements Harmonization Project](https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/covid-19-real-world-data-rwd-data-elements-harmonization-project)\nMapping spreadsheet of COVID-19 data elements to several Common Data Models (CDMs) and open standards\n\n### [FDA Sentinel System’s Coronavirus (COVID-19) Activities](https:\/\/www.sentinelinitiative.org\/drugs\/fda-sentinel-system-coronavirus-covid-19-activities)\nMonitors the use of drugs, describes the course of illness among hospitalized patients, and evaluates therapies\n\n## Paragraph Header CONTACT US\nContact Point\n\n[druginfo@fda.hhs.gov](mailto:druginfo@fda.hhs.gov)\n\nToll Free\n\n(855) 543-3784\n\n(301) 796-3400\n\nHours Available\n\nCenter for Drug Evaluation and Research (CDER)\n\n## For Latest Updates Follow\nContact Point Twitter\n\n## [@FDA\\_Drug\\_Info](https:\/\/twitter.com\/FDA_Drug_Info)\nYour source for the latest drug information.  \n Know the moment it happens.\n\n- ## Content current as of:\n  12\/29\/2023\n- ## Regulated Product(s)\n  - Drugs\n  ## Health Topic(s)\n  - Infectious Disease\n  - Coronavirus\n\nFeedback\n\n- [FDA Archive](https:\/\/www.fda.gov\/about-fda\/about-website\/fdagov-archive)\n- [About FDA](https:\/\/www.fda.gov\/about-fda)\n- [Accessibility](https:\/\/www.fda.gov\/about-fda\/about-website\/internet-accessibility)\n\n- [Visitor Information](https:\/\/www.fda.gov\/about-fda\/visitor-information)\n- [Website Policies \/ Privacy](https:\/\/www.fda.gov\/about-fda\/about-website\/website-policies)\n- [No FEAR Act](https:\/\/www.fda.gov\/about-fda\/jobs-and-training-fda\/no-fear-act)\n- [Vulnerability Disclosure Policy](https:\/\/www.hhs.gov\/vulnerability-disclosure-policy\/index.html)\n\n- [FOIA](https:\/\/www.fda.gov\/regulatory-information\/freedom-information \"Freedom of Information Act\")\n- [HHS.gov](https:\/\/www.hhs.gov\/ \"Health and Human Services\")\n- [USA.gov](https:\/\/www.usa.gov\/)\n\n[Contact FDA](https:\/\/www.fda.gov\/about-fda\/contact-fda)  [Follow FDA on Facebook](https:\/\/www.facebook.com\/FDA \"Follow FDA on Facebook\")\n\n[Follow FDA on X](https:\/\/x.com\/US_FDA \"Follow FDA on X\")\n\n[Follow FDA on Instagram](https:\/\/instagram.com\/FDA \"Follow FDA on Instagram\")    \n  [Follow FDA on LinkedIn](https:\/\/www.linkedin.com\/company\/fda\/ \"Follow FDA on LinkedIn\")   [View FDA videos on YouTube](https:\/\/youtube.com\/@US_FDA \"View FDA videos on YouTube\")   [Subscribe to FDA RSS feeds](https:\/\/www.fda.gov\/about-fda\/contact-fda\/subscribe-podcasts-and-news-feeds \"Subscribe to FDA RSS feeds\")\n\n[![Food and Drug Administration Logo](https:\/\/www.fda.gov\/themes\/custom\/preview\/assets\/images\/FDA_Logo_Icon_White.svg)](https:\/\/www.fda.gov\/ \"FDA Homepage\")\n\nContact Number 1-888-INFO-FDA (1-888-463-6332)\n\n[Back to Top](https:\/\/www.fda.gov\/drugs\/emergency-preparedness-drugs\/coronavirus-covid-19-drugs)","attrs_readable_markdown":"When FDA approves a drug, it means the agency has determined, among other things, that:\n\n- The drug is safe and effective for its intended use;\n- The benefits of the drug outweigh its risks when used according to its approved labeling;\n- The drug’s labeling (including the package insert) is appropriate; and\n- The methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity.\n\nThe statutory standard for an FDA-approval requires substantial evidence of effectiveness, which is a different level of evidence of effectiveness than required for an EUA.\n\nUnder section 564 of the Federal Food, Drug & Cosmetic Act (FD\\&C Act), FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services (HHS), authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, among other things, that:\n\n- Based on the totality of scientific evidence available-\n  - The product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent;\n  - That the known and potential benefits of the product, when used to diagnose, prevent or treat such disease or condition, outweigh the known and potential risks of the product; and\n- That there are no adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such disease or condition.\n\nFDA may [revise or revoke](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/faqs-what-happens-euas-when-public-health-emergency-ends \"FAQs: What happens to EUAs when a public health emergency ends?\") EUAs at any time, for example, when the drug receives FDA-approval and such product is sufficiently available to meet the public health demand, or when revision or revocation is appropriate to protect the public health or safety.\n\nFDA’s [EUA page](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/emergency-use-authorization \"Emergency Use Authorization\") has information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product fact sheets and additional information for health care professionals and patients. FDA and Health and Human Services Administration for Strategic Preparedness and [Response](https:\/\/aspr.hhs.gov\/Pages\/Home.aspx) have announced extensions to the shelf life for some EUA products. Find these updates on FDA’s [Expiration Dating Extension](https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/expiration-dating-extension \"Expiration Dating Extension\") page.\n\nLearn more about EUAs in [this video](https:\/\/www.youtube.com\/watch?v=iGkwaESsGBQ).  \n Read more about COVID-19 regulatory terminology on the [FDA website](https:\/\/www.fda.gov\/node\/393224).","meta_canonical":null}

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Boilerpipe Text	When FDA approves a drug, it means the agency has determined, among other things, that: The drug is safe and effective for its intended use; The benefits of the drug outweigh its risks when used according to its approved labeling; The drug’s labeling (including the package insert) is appropriate; and The methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity. The statutory standard for an FDA-approval requires substantial evidence of effectiveness, which is a different level of evidence of effectiveness than required for an EUA. Under section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services (HHS), authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, among other things, that: Based on the totality of scientific evidence available- The product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; That the known and potential benefits of the product, when used to diagnose, prevent or treat such disease or condition, outweigh the known and potential risks of the product; and That there are no adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such disease or condition. FDA may revise or revoke EUAs at any time, for example, when the drug receives FDA-approval and such product is sufficiently available to meet the public health demand, or when revision or revocation is appropriate to protect the public health or safety. FDA’s EUA page has information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product fact sheets and additional information for health care professionals and patients. FDA and Health and Human Services Administration for Strategic Preparedness and Response have announced extensions to the shelf life for some EUA products. Find these updates on FDA’s Expiration Dating Extension page. Learn more about EUAs in this video . Read more about COVID-19 regulatory terminology on the FDA website .
Markdown	- [Skip to main content](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#main-content) - [Skip to FDA Search](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#search-form) - [Skip to in this section menu](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#section-nav) - [Skip to footer links](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#footer) ![U.S. flag](https://www.fda.gov/themes/custom/preview/assets/images/US_Flag.png) An official website of the United States government [Here’s how you know](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs) ![Dot gov](https://www.fda.gov/themes/custom/preview/assets/images/icon-dot-gov.svg) The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. ![SSL](https://www.fda.gov/themes/custom/preview/assets/images/icon-https.svg) The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. [![U.S. Food and Drug Administration logo](https://www.fda.gov/themes/custom/preview/assets/images/FDA_Logo_Icon_White.svg)](https://www.fda.gov/ "FDA Homepage") - Search - Menu ## Featured - [Report a Product Problem](https://www.safetyreporting.hhs.gov/smarthub#/ "Report a Problem with an FDA Regulated Product") - [Contact FDA](https://www.fda.gov/about-fda/contact-fda) - [FDA Guidance Documents](https://www.fda.gov/regulatory-information/search-fda-guidance-documents) - [Recalls, Market Withdrawals and Safety Alerts](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts) - [Press Announcements](https://www.fda.gov/news-events/newsroom/press-announcements) - [Warning Letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters) - [Advisory Committees](https://www.fda.gov/advisory-committees) - [En Espa\&\#241ol](https://www.fda.gov/fda-en-espanol) ## Products - [Food](https://www.fda.gov/food) - [Drugs](https://www.fda.gov/drugs) - [Medical Devices](https://www.fda.gov/medical-devices) - [Radiation-Emitting Products](https://www.fda.gov/radiation-emitting-products) - [Vaccines, Blood, and Biologics](https://www.fda.gov/vaccines-blood-biologics) - [Animal and Veterinary](https://www.fda.gov/animal-veterinary) - [Cosmetics](https://www.fda.gov/cosmetics) - [Tobacco Products](https://www.fda.gov/tobacco-products) ## Topics - [About FDA](https://www.fda.gov/about-fda) - [Combination Products](https://www.fda.gov/combination-products) - [Regulatory Information](https://www.fda.gov/regulatory-information) - [Safety](https://www.fda.gov/safety) - [Emergency Preparedness](https://www.fda.gov/emergency-preparedness-and-response) - [International Programs](https://www.fda.gov/international-programs) - [News and Events](https://www.fda.gov/news-events) - [Training and Continuing Education](https://www.fda.gov/training-and-continuing-education) - [Inspections and Compliance](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations) - [Science and Research](https://www.fda.gov/science-research) ## Information For - [Consumers](https://www.fda.gov/consumers) - [Patients](https://www.fda.gov/patients) - [Industry](https://www.fda.gov/industry) - [Health Professionals](https://www.fda.gov/health-professionals) - [Federal, State and Local Officials](https://www.fda.gov/federal-state-local-tribal-and-territorial-officials) [In this section: Emergency Preparedness \\| Drugs](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#section-nav) - [Coronavirus (COVID-19) \\| Drugs](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs) - [Coronavirus Treatment Acceleration Program (CTAP)](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap) - [CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products \\| COVID-19](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological) 1. [Home](https://www.fda.gov/) 2. [Drugs](https://www.fda.gov/drugs) 3. [Emergency Preparedness \\| Drugs](https://www.fda.gov/drugs/emergency-preparedness-drugs) 4. [Coronavirus (COVID-19) \\| Drugs]() 1. [Emergency Preparedness \\| Drugs](https://www.fda.gov/drugs/emergency-preparedness-drugs "Emergency Preparedness \| Drugs") # Coronavirus (COVID-19) \\| Drugs - [Coronavirus (COVID-19) \\| Drugs](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs) - [Coronavirus Treatment Acceleration Program (CTAP)](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap) - [CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products \\| COVID-19](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological) [Español](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-covid-19-medicamentos "Coronavirus (COVID-19) \| Medicamentos") In response to the novel coronavirus (COVID-19), FDA quickly created, in March 2020, the Coronavirus Treatment Acceleration Program (CTAP), which was designed to help facilitate the development of drugs and biological products (other than vaccines) for COVID-19 therapeutics. The development of COVID-19 therapeutics that are effective against current and future variants remains a critical priority. CTAP is leveraging the agency’s scientific experience and knowledge of COVID-19 to support current and future clinical trials testing new treatments for COVID-19. From these efforts, we continue to gain valuable knowledge about the safety and effectiveness of potential therapies for COVID-19. ## COVID-19 Therapeutics ## [What is the difference between FDA approved drugs and drugs authorized under an emergency use authorization (EUA)?](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#69da86e870310) When FDA approves a drug, it means the agency has determined, among other things, that: - The drug is safe and effective for its intended use; - The benefits of the drug outweigh its risks when used according to its approved labeling; - The drug’s labeling (including the package insert) is appropriate; and - The methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity. The statutory standard for an FDA-approval requires substantial evidence of effectiveness, which is a different level of evidence of effectiveness than required for an EUA. Under section 564 of the Federal Food, Drug & Cosmetic Act (FD\&C Act), FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services (HHS), authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, among other things, that: - Based on the totality of scientific evidence available- - The product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; - That the known and potential benefits of the product, when used to diagnose, prevent or treat such disease or condition, outweigh the known and potential risks of the product; and - That there are no adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such disease or condition. FDA may [revise or revoke](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends "FAQs: What happens to EUAs when a public health emergency ends?") EUAs at any time, for example, when the drug receives FDA-approval and such product is sufficiently available to meet the public health demand, or when revision or revocation is appropriate to protect the public health or safety. FDA’s [EUA page](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization "Emergency Use Authorization") has information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product fact sheets and additional information for health care professionals and patients. FDA and Health and Human Services Administration for Strategic Preparedness and [Response](https://aspr.hhs.gov/Pages/Home.aspx) have announced extensions to the shelf life for some EUA products. Find these updates on FDA’s [Expiration Dating Extension](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension "Expiration Dating Extension") page. Learn more about EUAs in [this video](https://www.youtube.com/watch?v=iGkwaESsGBQ). Read more about COVID-19 regulatory terminology on the [FDA website](https://www.fda.gov/node/393224). ## [Types of Treatments (Approved or under EUA)](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#69da86e870c2a) - Antiviral Drugs Antiviral drugs are medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against viruses in your body. - Immune Modulators Immune modulators are medicines that help activate, boost, or suppress the immune function. In the case of COVID-19 infection, the immune system can become hyperactive which may result in worsening of disease. Immune modulators can help suppress this hyperinflammation. - Monoclonal Antibodies (mAbs) targeting SARS-COV-2 SARS-COV-2-targeting mAbs are laboratory-produced antibodies that can help the immune system's attack on SARS-COV-2. These mAbs block entry of SARS-CoV-2 into human cells, thus neutralizing the virus. SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains. Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19. - Renal Replacement Therapy Solutions Continuous renal replacement therapy (CRRT) is a type of “dialysis,” which is a machine treatment that filters and purifies the blood when a patient’s kidneys are damaged or are not functioning normally. CRRT is used for patients with kidney injury in acute care settings. SARS-CoV-2 led to an increased population with critical illness and multiple organ failure, including acute kidney injury, increasing the need for CRRT. In addition, there was an insufficient supply of replacement solutions to meet the emergency need to provide CRRT in critically ill patients. ## [FDA Approved or Authorized Drugs to Reduce the Risk of Hospitalization or Death for Patients with Mild to Moderate COVID-19](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#69da86e870cb3) - [Paxlovid (nirmatrelvir and ritonavir)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf) is an antiviral drug, approved for certain adults and authorized under EUA for adolescents - [Veklury (remdesivir)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s024lbl.pdf) in an antiviral drug, approved for certain adults and children - [Lagevrio (molnupiravir)](https://www.fda.gov/media/155053/download?attachment) is an antiviral drug, authorized under EUA for certain adults ## [FDA Approved or Authorized Drugs or Renal Replacement Therapy Solutions to Treat or Support Patients Hospitalized Due to COVID-19](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#69da86e870d23) - [Actemra (tocilizumab)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s138lbl.pdf) is an immune modulator drug, approved for certain adults, authorized under EUA for certain children - [Olumiant (baricitinib)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s007lbl.pdf) is an immune modulator drug, approved for certain adults, authorized under EUA for certain children - [Veklury (remdesivir)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf) is an antiviral drug, approved for certain adults and certain infants and children) - [Kineret (anakinra)](https://www.fda.gov/media/163081/download?attachment "Kineret LOA 11082022") is an immune modulator drug, authorized under EUA for certain adults - [Gohibic (vilobelimab)](https://www.fda.gov/media/166823/download?attachment "Gohibic Emergency Use Authorization") is an immune modulator drug, authorized under EUA for certain adults - [Regiocit replacement solution](https://www.fda.gov/media/141168/download?attachment "REVOKED_Regiocit EUA Letter of Authorization") is a renal replacement therapy solution, authorized under EUA for certain adults - [Fresenius Medical multiFiltrate/multiBic/multiPlus replacement solutions](https://www.fda.gov/media/137520/download?attachment "REVOKED_Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions - Letter of Authorization") are renal replacement therapy solutions, authorized under EUA for certain adults ## [Other Resources](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs#69da86e870da1) - [Know Your Treatment Options for COVID-19](https://www.fda.gov/consumers/consumer-updates/know-your-treatment-options-covid-19 "Know Your Treatment Options for COVID-19") - [Emergency Use Authorizations for Drugs](https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products "Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products") - [CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products \\| COVID-19](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological "CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products \| COVID-19") - [COVID-19 Therapeutics Expiration Dating Extensions](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension#COVIDtherapeutics "Expiration Dating Extension") - [Coronavirus Treatment Acceleration Program (CTAP)](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap "Coronavirus Treatment Acceleration Program (CTAP)") - [Revoked EUAs for COVID-19](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#covid19 "Emergency Use Authorization--Archived Information") - [Coronavirus (COVID-19) \\| CBER-Regulated Biologics](https://www.fda.gov/vaccines-blood-biologics/industry-biologics/coronavirus-covid-19-cber-regulated-biologics "Coronavirus (COVID-19) \| CBER-Regulated Biologics") - [At-Home OTC COVID-19 Diagnostic Tests](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests "At-Home OTC COVID-19 Diagnostic Tests") - [FDA Coronavirus Disease 2019 (COVID-19)](https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19 "Coronavirus Disease 2019 (COVID-19)") - [What Happens to EUAs when a public health emergency ends?](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends "FAQs: What happens to EUAs when a public health emergency ends?") - [USG COVID-19 Home Page](https://www.covid.gov/) Sub-Topic Paragraphs ## Additional Resources ### [Coronavirus Treatment Acceleration Program (CTAP)](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap) Acceleration of development for COVID-19 treatments ## Additional Resources ### [COVID-19 Treatment Hub](https://reaganudall.org/covid-19) Provides physicians, patients, and caregivers with information about the latest research in the fight against COVID-19 ### [COVID-19 Test to Treat Locator](https://aspr.hhs.gov/testtotreat/Pages/default.aspx) Faster, Easier Access to Life‑Saving COVID‑19 Treatments ### [COVID-19 Real World Data (RWD) Data Elements Harmonization Project](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/covid-19-real-world-data-rwd-data-elements-harmonization-project) Mapping spreadsheet of COVID-19 data elements to several Common Data Models (CDMs) and open standards ### [FDA Sentinel System’s Coronavirus (COVID-19) Activities](https://www.sentinelinitiative.org/drugs/fda-sentinel-system-coronavirus-covid-19-activities) Monitors the use of drugs, describes the course of illness among hospitalized patients, and evaluates therapies ## Paragraph Header CONTACT US Contact Point [druginfo@fda.hhs.gov](mailto:druginfo@fda.hhs.gov) Toll Free (855) 543-3784 (301) 796-3400 Hours Available Center for Drug Evaluation and Research (CDER) ## For Latest Updates Follow Contact Point Twitter ## [@FDA\_Drug\_Info](https://twitter.com/FDA_Drug_Info) Your source for the latest drug information. Know the moment it happens. - ## Content current as of: 12/29/2023 - ## Regulated Product(s) - Drugs ## Health Topic(s) - Infectious Disease - Coronavirus Feedback - [FDA Archive](https://www.fda.gov/about-fda/about-website/fdagov-archive) - [About FDA](https://www.fda.gov/about-fda) - [Accessibility](https://www.fda.gov/about-fda/about-website/internet-accessibility) - [Visitor Information](https://www.fda.gov/about-fda/visitor-information) - [Website Policies / Privacy](https://www.fda.gov/about-fda/about-website/website-policies) - [No FEAR Act](https://www.fda.gov/about-fda/jobs-and-training-fda/no-fear-act) - [Vulnerability Disclosure Policy](https://www.hhs.gov/vulnerability-disclosure-policy/index.html) - [FOIA](https://www.fda.gov/regulatory-information/freedom-information "Freedom of Information Act") - [HHS.gov](https://www.hhs.gov/ "Health and Human Services") - [USA.gov](https://www.usa.gov/) [Contact FDA](https://www.fda.gov/about-fda/contact-fda) [Follow FDA on Facebook](https://www.facebook.com/FDA "Follow FDA on Facebook") [Follow FDA on X](https://x.com/US_FDA "Follow FDA on X") [Follow FDA on Instagram](https://instagram.com/FDA "Follow FDA on Instagram") [Follow FDA on LinkedIn](https://www.linkedin.com/company/fda/ "Follow FDA on LinkedIn") [View FDA videos on YouTube](https://youtube.com/@US_FDA "View FDA videos on YouTube") [Subscribe to FDA RSS feeds](https://www.fda.gov/about-fda/contact-fda/subscribe-podcasts-and-news-feeds "Subscribe to FDA RSS feeds") [![Food and Drug Administration Logo](https://www.fda.gov/themes/custom/preview/assets/images/FDA_Logo_Icon_White.svg)](https://www.fda.gov/ "FDA Homepage") Contact Number 1-888-INFO-FDA (1-888-463-6332) [Back to Top](https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs)
Readable Markdown	When FDA approves a drug, it means the agency has determined, among other things, that: - The drug is safe and effective for its intended use; - The benefits of the drug outweigh its risks when used according to its approved labeling; - The drug’s labeling (including the package insert) is appropriate; and - The methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity. The statutory standard for an FDA-approval requires substantial evidence of effectiveness, which is a different level of evidence of effectiveness than required for an EUA. Under section 564 of the Federal Food, Drug & Cosmetic Act (FD\&C Act), FDA may, pursuant to a determination and declaration by the Secretary of the Department of Health and Human Services (HHS), authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, among other things, that: - Based on the totality of scientific evidence available- - The product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; - That the known and potential benefits of the product, when used to diagnose, prevent or treat such disease or condition, outweigh the known and potential risks of the product; and - That there are no adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such disease or condition. FDA may [revise or revoke](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends "FAQs: What happens to EUAs when a public health emergency ends?") EUAs at any time, for example, when the drug receives FDA-approval and such product is sufficiently available to meet the public health demand, or when revision or revocation is appropriate to protect the public health or safety. FDA’s [EUA page](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization "Emergency Use Authorization") has information about vaccine and therapeutic products currently authorized under an EUA, as well as the current product fact sheets and additional information for health care professionals and patients. FDA and Health and Human Services Administration for Strategic Preparedness and [Response](https://aspr.hhs.gov/Pages/Home.aspx) have announced extensions to the shelf life for some EUA products. Find these updates on FDA’s [Expiration Dating Extension](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension "Expiration Dating Extension") page. Learn more about EUAs in [this video](https://www.youtube.com/watch?v=iGkwaESsGBQ). Read more about COVID-19 regulatory terminology on the [FDA website](https://www.fda.gov/node/393224).
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