U.S. flag An official website of the United States government
  1. Inicio
  2. Emergency Preparedness and Response
  3. Counterterrorism and Emerging Threats
  4. Medical Countermeasures Initiative (MCMi)
  5. MCM Issues
  6. Coronavirus Disease 2019 (COVID-19)
  1. MCM Issues

Coronavirus Disease 2019 (COVID-19)

images of FDA-regulated products: blood donation, vaccines, diagnostic tests food, medicines

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

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:

For more information from CDC, visit Coronavirus Disease 2019 (COVID-19).

back to top

Woman looking at computer with man in the background


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. 

back to top

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:

  • 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?

  • Providing regulatory advice, guidance, and technical assistance to sponsors developing investigational MCMs for emerging threat indications.

  • Working with medical product sponsors to clarify regulatory and data requirements necessary to rapidly advance development of products essential to supporting response efforts.

  • 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.

  • 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

  • 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.

  • 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.

back to top

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.


Personal Protective Equipment


  • 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.


  • 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.

back to top

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. 

back to top

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.

back to top

Press Releases and Public Statements

back to top


back to top

Additional resources

back to top

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.

back to top


Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures, 2019-nCoV, and other emerging infectious diseases.

Back to Top