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FDA is working with U.S. Government partners, including CDC, and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.

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FDA is working with U.S. Government partners, including CDC, and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.

For updates on Twitter, follow @SteveFDA, @US_FDA, @FDA_Global and @FDA_MCMi.

What’s new

  • 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: The FDA granted an Emergency Use Authorization to two public health laboratories in New York for a diagnostic test to identify COVID-19.
  • February 29, 2020Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics – As part of the FDA’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new 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 template for these EUA submissions is available. If you need additional information completing the template or wish to consider use of an alternative specimen type, please contact the Division of Microbiology Devices at (301) 348-1778 or email [email protected].
  • 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 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.
  • 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.

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 though still relatively low 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).

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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 2019-nCoV and other conditions and takes appropriate action to protect consumers.

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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

Vaccines

  • There are no FDA-approved vaccines to prevent COVID-19 or other coronaviruses.
  • Biological product sponsors, including vaccine developers, can email [email protected] 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.

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.

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Press releases and statements

  • 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, 2020Coronavirus (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.”

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Events

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Additional resources

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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 [email protected] or call 301-796-4540

COVID-19 Therapeutics: General Information for Interested Stakeholders
For therapeutics sponsors interested in submitting drug development proposals for review

Request additional information on completing the diagnostic test EUA template or to consider use of an alternative specimen type, please contact call (301) 348-1778 or email [email protected].

Biological product sponsors, including vaccine developers
Email [email protected] or call 1-800-835-4709 for further information.

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