Coronavirus Disease 2019 (COVID-19)
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The President's Coronavirus Guidelines for America - 15 Days to Slow the Spread of Coronavirus (COVID-19). More at Whitehouse.gov.
For updates on Twitter, follow @SteveFDA, @US_FDA, @FDA_Global and @FDA_MCMi.
What's new
- March 25, 2020: Coronavirus (COVID-19) Update: Daily Roundup - Today's actions in our ongoing response to the COVID-19 epidemic.
- March 24, 2020: Coronavirus (COVID-19) Update: Daily Roundup - Actions by the FDA in our ongoing response to the COViD-19 pandemic.
- March 24, 2020: FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19 - The U.S. food supply remains safe for both people and animals during the COVID-19 pandemic.
- March 24, 2020: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers - The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices.
- March 24, 2020: Investigational COVID-19 Convalescent Plasma - Emergency INDs - information for healthcare providers about convalescent plasma—plasma collected from the blood of fully recovered COVID-19 patients and given as treatment to very ill COVID-19 patients.
- March 24, 2020: Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic - The FDA announced today that it intends to temporarily not enforce certain requirements in order to allow veterinarians to better utilize telemedicine to address animal health needs during the pandemic.
- March 23, 2020: Coronavirus (COVID-19) Update: Daily Roundup - Actions by the FDA in our ongoing response to the COVID-19 pandemic
- March 23, 2020: FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development - FDA and the European Medicines Agency jointly chaired the first global regulators meeting to discuss ways to streamline the development of SARS-CoV-2 vaccines.
- March 22, 2020: Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency - The FDA issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.
- March 22, 2020: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators - The FDA took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.
- March 21, 2020: Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic - The FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.
- March 20, 2020: Medical Glove Conservation Strategies: Letter to Health Care Providers - The conservation strategies for use by health care organizations and personnel are categorized for a range of needs and supply levels and are intended to assist health care organizations as they determine procedures during the COVID-19 pandemic.
- March 20, 2020: Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits - The FDA is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.
- March 20, 2020: Preguntas más frecuentes acerca de la Enfermedad del Coronavirus 2019 (COVID-19) – Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions are now available in Spanish.
- March 20, 2020: Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely - The FDA issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.
- March 20, 2020: Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health - As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
- March 19, 2020: DHS Issues Guidance on the Essential Critical Infrastructure Workforce - The Department of Homeland Security (DHS)/Cybersecurity & Infrastructure Agency (CISA) issued new guidance to support state, local, and industry partners in identifying the critical infrastructure sectors and the essential workers needed to maintain the services and functions Americans depend on daily and need to be able to operate resiliently during the COVID-19 pandemic response. This includes essential workers in the food, health care, and public health sectors, including FDA-regulated industries.
- March 19, 2020: FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19 - At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available.
- March 19, 2020: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments - The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.
- March 19, 2020: Coronavirus (COVID-19) Update: Blood Donations - The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year. At this time the number of blood donations has been dramatically reduced due to the implementation of social distancing and the cancellation of blood drives. In order to ensure that blood is available to those who need it most, it is important for healthy individuals who are able to donate to take the time to do so.
Please Be Advised
In light of the public health emergency declared for the Novel Coronavirus, visitors to FDA campuses and buildings may be asked questions related to recent international travel.
Additional resources:
HHS Secretary Declaration | CDC Risk Assessment | CDC Coronavirus Page
Fast facts
FDA is working with U.S. Government partners, including the U.S. Centers for Disease Control and Prevention (CDC), and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.
The virus has been named “SARS-CoV-2” and the disease it causes has been named “coronavirus disease 2019” (abbreviated “COVID-19”).
While the U.S. Government considers this a serious public health concern, based on current information, the CDC has determined that the immediate health risk from COVID-19 to the general American public is considered low at this time. People in communities where ongoing community spread with the virus that causes COVID-19 has been reported are at elevated risk of exposure. Travelers returning from affected international locations, close contacts of persons with COVID-19, and healthcare workers caring for patients with COVID-19 are at elevated risk of exposure.
COVID-19 resources from CDC include:
- Situation Summary
- Frequently Asked Questions and Answers
- Information for Healthcare Professionals
- Information for Laboratories
- Information for Travelers
- Animals and Coronavirus Disease 2019 (COVID-19)
For more information from CDC, visit Coronavirus Disease 2019 (COVID-19).
Frequently Asked Questions
Answers to questions the general public and consumers may have about COVID-19, including general information and details on biologics (vaccines, human tissues and blood products), medicines, medical devices and diagnostic tests, and food.
- Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions (inglés)
- Preguntas más frecuentes acerca de la Enfermedad del Coronavirus 2019 (COVID-19) (Spanish)
FDA's role
FDA plays a critical role in protecting the United States from threats including emerging infectious diseases. In collaboration with interagency partners, product developers, international partners and global regulators, FDA’s roles in preparedness and response include:
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Facilitating the development and availability of medical countermeasures (MCMs) that can be used to diagnose, prevent, or treat emerging diseases. Also see: What are medical countermeasures?
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Providing regulatory advice, guidance, and technical assistance to sponsors developing investigational MCMs for emerging threat indications.
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Working with medical product sponsors to clarify regulatory and data requirements necessary to rapidly advance development of products essential to supporting response efforts.
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Providing review and feedback on development proposals including design and set-up of clinical trials for establishing the safety and efficacy of investigational products and data assessment.
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Protecting the safety of the nation’s blood supply and human cells, tissues, and cellular/tissue-based products (HCT/Ps) for transplantation. Also see: Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak and Important Information for HCT/P Establishments Regarding the 2019 Novel Coronavirus Outbreak
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Enabling access to investigational MCMs—when necessary—through an appropriate mechanism such as under an Emergency Use Authorization (EUA) or under expanded access mechanisms when the clinical circumstances warrant.
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Protecting consumers against fraudulent products - Unfortunately, during emergency situations or outbreaks, fraudulent products claiming to prevent, treat or cure conditions associated with the emergency or outbreak almost always appear for sale. The FDA monitors for fraudulent products and false product claims related to COVID-19 and other conditions and takes appropriate action to protect consumers.
Medical countermeasures
There are currently no FDA-approved medical countermeasures for COVID-19. FDA stands ready to work with medical product developers to clarify regulatory and data requirements necessary to move products forward in development as quickly as possible.
Diagnostics
- There are no FDA-approved diagnostics for COVID-19.
- Diagnostic Emergency Use Authorizations (EUAs):
- More information on EUAs for novel coronavirus (COVID-19) diagnostic tests is available on our website.
- On March 16, 2020, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S.
- On February 29, 2020, the FDA issued an immediately in effect guidance, Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. The templates for these diagnostic testing EUA submissions are available (updated March 6, 2020). If you need additional information, please refer to the FAQs on Diagnostic Testing for SARS-CoV-2.
- On February 4, 2020, FDA authorized emergency use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. For additional technical information and fact sheets, see: Emergency Use Authorizations (Devices). Also see from CDC: Information for Laboratories COVID-19 Requests for Diagnostic Panels and Virus
- Coronavirus (COVID-19) Diagnostic Tests Hotline
- For test developers and labs who have questions about the EUA process or spot shortages of testing supplies.
- Contact our toll-free phone line 24 hours a day: 1-888-INFO-FDA (1-888-463-6332), then press star (*)
Personal Protective Equipment
- On March 20, 2020, the FDA issued Medical Glove Conservation Strategies: Letter to Health Care Providers - The conservation strategies for use by health care organizations and personnel are categorized for a range of needs and supply levels and are intended to assist health care organizations as they determine procedures during the COVID-19 pandemic.
- On March 11, 2020, the FDA issued Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers - The conservation strategies are intended to assist healthcare organizations as they determine operating procedures during the COVID-19 outbreak. The FDA is also collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. Also see: FAQs on Shortages of Surgical Masks and Gowns.
- On March 2, 2020, the FDA and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. The FDA granted the CDC’s request for an Emergency Use Authorization (EUA) to allow health care personnel to use certain industrial respirators during the COVID-19 outbreak in health care settings. A list of respirators eligible for Emergency Use Authorization (EUA) is available in Appendix A and a list of respirators authorized under the EUA is available in Appendix B of the EUA’s letter of authorization.
Vaccines
- There are no FDA-approved vaccines to prevent COVID-19 or other coronaviruses.
- Biological product sponsors, including vaccine developers, can email industry.biologics@fda.hhs.gov or call 1-800-835-4709 for further information.
Therapeutics
- There are no FDA-approved therapeutics (drugs) to treat COVID-19 or other coronaviruses.
- Sponsors wishing to develop therapeutics are encouraged to submit information and questions via the Pre-IND Consultation program (see the web page or call 301-796-1500 for additional information on this program). Information regarding any clinical trials that may be initiated may be searched for at www.ClinicalTrials.gov.
- FDA is working closely with product sponsors to speed development of COVID-19 treatments. On February 25, 2020, the National Institutes of Health began a randomized controlled trial for the treatment of COVID-19 patients. While sponsors are usually expected to allow 30 days between submission and initiation of an initial IND protocol to allow for safety review, FDA has been using both pre-IND discussions and highly expedited initial review to allow such trials to begin as soon as possible. We continue to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate.
- On March 24, 2020, the FDA issued information for healthcare providers about convalescent plasma—plasma collected from the blood of fully recovered COVID-19 patients and given as treatment to very ill COVID-19 patients: Investigational COVID-19 Convalescent Plasma - Emergency INDs.
For product developers
The Biomedical Advanced Research and Development Authority (BARDA), a component of the HHS Assistant Secretary of Preparedness and Response (ASPR), is supporting U.S. government market research to identify medical countermeasures with the potential to help address the COVID-19 outbreak. If your company is developing diagnostics, therapeutics, vaccines, or other products, submit your ideas to BARDA's online portal.
Also see above for FDA information for product developers regarding specific types of MCMs.
COVID-19-Related Guidance Documents
The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. To assist our stakeholders in locating timely information, the FDA has created a webpage listing COVID-19 related guidance documents for industry, FDA staff, and other stakeholders.
Health Fraud
- Fraudulent Coronavirus Disease 2019 (COVID-19) Products - The FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, or injunctions against products and firms or individuals that violate the law.
Press Releases and Public Statements
- March 24, 2020: Coronavirus (COVID-19) Update: Daily Roundup - Actions by the FDA in our ongoing response to the COViD-19 pandemic.
- March 24, 2020: FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19 - The U.S. food supply remains safe for both people and animals during the COVID-19 pandemic.
- March 24, 2020: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers - The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices.
- March 24, 2020: Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic - The FDA announced today that it intends to temporarily not enforce certain requirements in order to allow veterinarians to better utilize telemedicine to address animal health needs during the pandemic.
- March 23, 2020: Coronavirus (COVID-19) Update: Daily Roundup - Actions by the FDA in our ongoing response to the COVID-19 pandemic
- March 23, 2020: FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development - FDA and the European Medicines Agency jointly chaired the first global regulators meeting to discuss ways to streamline the development of SARS-CoV-2 vaccines.
- March 22, 2020: Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency - The FDA issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.
- March 22, 2020: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators - The FDA took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.
- March 21, 2020: Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic - The FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.
- March 20, 2020: Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits - The FDA is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.
- March 20, 2020: Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely - The FDA issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.
- March 20, 2020: Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health - As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
- March 19, 2020: FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19 - At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available.
- March 19, 2020: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments - The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.
- March 19, 2020: Coronavirus (COVID-19) Update: Blood Donations - The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year. At this time the number of blood donations has been dramatically reduced due to the implementation of social distancing and the cancellation of blood drives. In order to ensure that blood is available to those who need it most, it is important for healthy individuals who are able to donate to take the time to do so.
- March 18, 2020: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections - For the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.
- March 18, 2020: Coronavirus (COVID-19) Update: FDA issues a guidance on conducting clinical trials during the pandemic - The FDA took steps to help industry and investigators navigate the COVID-19 pandemic and move forward with conducting clinical trials.
- March 17, 2020: Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements - The FDA took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.
- March 16, 2020: Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp - The FDA took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
- March 16, 2020: Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics - The FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S.
- March 13, 2020: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher - The FDA took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit.
- March 12, 2020: Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic - The two significant actions will expedite the availability of diagnostic tests.
- March 10, 2020: Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections - After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.
- March 9, 2020: Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 - The FDA and the Federal Trade Commission issued warning letters to seven companies for selling fraudulent COVID-19 products. These products are unapproved drugs that pose significant risks to patient health and violate federal law. The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak.
- March 2, 2020: Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel - In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.
- February 29, 2020: Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics - As part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.
- February 27, 2020: Coronavirus (COVID-19) Supply Chain Update - FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.
- February 24, 2020: Coronavirus Update: FDA steps to ensure quality of foreign products - FDA continues to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity.
- February 14, 2020: FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad - FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.
- February 11, 2020: The World Health Organization announced an official name for the disease that is causing the current outbreak of coronavirus disease, COVID-19. FDA's website has been updated to reflect the updated name.
- February 5, 2020: CDC Media Telebriefing: Update on 2019 Novel Coronavirus (COVID-19), including updates from FDA Chief Scientist RADM Denise Hinton
- February 4, 2020: FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic - FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.
- January 30, 2020: The HHS Assistant Secretary for Preparedness and Response (ASPR) hosted a stakeholder listening session (transcript PDF) to discuss medical countermeasure challenges associated with 2019-nCoV outbreak. FDA Acting Assistant Commissioner for Counterterrorism Policy Michael Mair provided FDA remarks.
- January 27, 2020: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures - “We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”
Events
- March 18, 2020: FDA Briefing for Foods Stakeholders on Coronavirus Disease 2019 (COVID-19) - The FDA hosted a stakeholder call to discuss food safety and food supply questions, respond to concerns, and highlight key FDA resources for the response to the COVID-19 pandemic.
- March 7, 2020: Coronavirus (COVID-19) Update: White House Press Briefing by FDA Commissioner Stephen M. Hahn, M.D.
- March 6, 2020 - Virtual Town Hall - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - The FDA hosted a town hall for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) that are developing or have developed molecular diagnostic tests for SARS-CoV-2.
- March 4, 2020 - Remarks by FDA Commissioner Stephen Hahn to the American Clinical Laboratory Association - The Commissioner's remarks highlighted the role of diagnostic testing in the COVID-19 response.
- March 3, 2020 - HHS officials testified at a Senate HELP Hearing, An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus.
- Remarks by Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services; and Dr. Stephen Hahn, Commissioner, U.S. Food and Drug Administration
- March 2, 2020 - Webinar: Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - The FDA hosted a webinar for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), and others interested in learning more about this guidance.
Additional resources
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Government Response to Coronavirus, COVID-19 - Learn what the U.S. government is doing in response to the virus.
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Coronavirus information from the World Health Organization (WHO)
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FAQ videos on COVID-19 (CDC), including Should I wear a mask, How to protect against COVID-19, and more
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Resources for State, Local, Territorial and Tribal Health Departments (CDC) - including interim guidance for risk assessment and monitoring
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2019 Novel Coronavirus (COVID-19) (Occupational Safety and Health Administration (OSHA), U.S. Department of Labor)
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Coronavirus disease (COVID-19) advice for the public, including how to protect yourself and others from getting sick (WHO)
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Secretary Azar Declares Public Health Emergency for United States for 2019 Novel Coronavirus (HHS, January 31, 2020)
Contact FDA
Consumers and general information: contact FDA
You may also call 1-888-INFO-FDA / (1-888-463-6332)
Report a fraudulent COVID-19 product
Includes options for phone and online reporting
Report a Product Shortage or Supply Issue to FDA
Each Center within FDA tracks shortages and supply issues for the products that it regulates.
Press: contact the Office of Media Affairs
Email fdaoma@fda.hhs.gov or call 301-796-4540
COVID-19 Therapeutics: General Information for Interested Stakeholders
For therapeutics sponsors interested in submitting drug development proposals for review
See FAQs on Diagnostic Testing for SARS-CoV-2. If you need additional information about completing the EUA template, would like to know how to submit your Pre-EUA/EUA submission to FDA, or wish to consider use of an alternative specimen type, please contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.gov.
Biological product sponsors, including vaccine developers
Email industry.biologics@fda.hhs.gov or call 1-800-835-4709 for further information.