COVID-19 FAQ

COVID-19 Diagnostic Tests:
For questions about development of COVID-19 diagnostic tests, there are several important resources you can use:

  • 24/7 Hotline for Diagnostics:  If a developer, lab, manufacturer or health care provider has questions about testing or is experiencing spot shortages of testing, personal protective equipment, or other supplies, they should call our toll-free line at 1-888-463-6332 (1-888-INFO-FDA), then choose option (*). The line is available 24 hours a day to help address difficulties obtaining supplies for collecting patient samples for COVID-19 testing, including swabs, media needed for transport, and conservation of the samples – among other things. Please note, however, that FDA does not control the production volume or distribution of medical devices.
  • Emergency Use Authorization (EUA) for COVID-19 Diagnostic Tests: If you need additional information for completing the EUA template, would like to know how to submit Pre-EUA/EUA submissions to FDA, or wish to consider an alternative specimen type, you may contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.gov. As noted above, FDA must prioritize and is unable to provide information on the status of any individual submissions (this is generally confidential commercial information) and FDA would encourage congressional offices to reach out to specific developers for the status of any pending product submissions.


Personal Protective Equipment:
If a health care provider has questions or is experiencing spot shortages of personal protective equipment or other supplies, they should call our toll-free line at 1-888-463-6332 (1-888-INFO-FDA), then choose option (*). The line is available 24 hours a day to help address difficulties obtaining supplies. Please note, however, that FDA does not control the production volume or distribution of medical devices.

Drug Shortages:
FDA continues to take steps to monitor the supply chain.  The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak.  If you are a health care provider and have questions or concerns about a drug shortage, related or unrelated to COVID-19, you should contact CDER’s Division of Drug Information (DDI) at 855-543-3784, 301-796-3400, or druginfo@fda.hhs.gov. Also, FDA’s Drug Shortage web page has information related to current shortages.

Chloroquine/Hydroxychloroquine:
There has been significant public interest in the drugs chloroquine and hydroxychloroquine. FDA has published an FAQ on the subject here: https://www.fda.gov/media/136784/download.

Hand Sanitizer:
If you would like to manufacture or donate hand sanitizer, as many distilleries across the First District have, you can consult https://www.fda.gov/drugs/coronavirus-covid-19-drugs/hand-sanitizers-covid-19  if you have questions, or contact COVID-19-Hand-Sanitizers@fda.hhs.gov.

The FDA’s latest guidance documents are available here:

Businesses:
If you are a business and would like to produce, sell, or donate medical products to help with the COVID-19 response, please consult https://www.fema.gov/coronavirus/how-to-help.

Importation:
If you have a shipment of COVID-19 supplies held up at a port of entry, visit https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/importing-covid-19-supplies for contact information and instructions. It includes an interactive map that importers can use to find the right office for their shipment, based on where the product is entering the United States. To speed assistance, they should provide the customs entry number (the 11-digit number they can get from their filer), the port of entry, and other shipment details. (If you need assistance with import procedures regarding personal protective equipment or test kits should email COVID19FDAImportInquiries@fda.hhs.gov.)

Vaccines and Other Biological Product Candidates:
Biological product sponsors, including vaccine developers, wishing to develop vaccines can email industry.biologics@fda.hhs.gov or call 1-800-835-4709 for further information.

Therapeutic Candidates:
Developers who believe their investigational product may have activity against the COVID-19 virus and have relevant cell culture and/or animal model data may submit a Pre-IND (PIND) application to the Agency as a “general correspondence” via the Pre-IND Consultation program. See https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-therapeutics-general-information-interested-stakeholders or call 301-796-1500 for additional information on this program.

Drug Product Candidates:
Inquiries regarding product development for proposed COVID-19 uses should be sent to COVID19-productdevelopment@fda.hhs.gov. Product sponsors can read more about the Coronavirus Treatment Acceleration Program at https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap.

It’s also recommend they review COVID-19 Therapeutics: General Information for Interested Stakeholders for additional information.

Clinical Trials:
Sponsors who have questions regarding the conduct of clinical trials impacted by COVID-19 should contact clinicaltrialconduct-COVID19@fda.hhs.gov.

Food:
If you have food safety questions related COVID-19 you can find more information at https://www.fda.gov/food/food-safety-during-emergencies/food-safety-and-coronavirus-disease-2019-covid-19. If you need to contact FDA’s Center for Food Safety and Applied Nutrition about a COVID-19 related question, you may do so by submitting a question here.

Animal Drugs and Animal Food:
If you have questions or concerns related to COVID-19 and its impact on products regulated by FDA’s Center for Veterinary Medicine, you may contact AskCVM@fda.hhs.gov, and your inquiry will be routed to the appropriate subject matter expert for response. A list of known animal drug shortages is kept by FDA’s Center for Veterinary Medicine.

Topic-Specific FAQs:

FDA’s COVID-19 FAQ: for questions related to vaccines, biologics, human tissue products, drugs, medical devices and tests, and food products.
Healthcare Professionals
Diagnostic Testing
Emergency Use Authorizations
Food Safety for Industry

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