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  1. MCM Issues

COVID-19 Therapeutics: General Information for Interested Stakeholders

We have pulled together some general information that may be useful to sponsors wishing to rapidly initiate interactions with the FDA regarding potential development of therapeutics for the COVID-19 virus. 

  • If you feel your investigational product may have activity against the COVID-19 virus and have relevant cell culture and/or animal model data, you may submit a Pre-IND (PIND) application to the Agency as a “general correspondence.” We highly recommend that you include all relevant information for review. If you feel your product’s stage of development warrants a formal Pre-IND meeting, please refer to the Division of Antivirals Pre-IND letter of instruction website for details.
  • A pre-assigned PIND number can be obtained from the following website: Requesting a Pre-Assigned Application Number

    Sponsors can submit their PIND submissions(s) either electronically or via paper.

    Electronic Submission Information (via ESG)

    For information about submitting electronically to CDER, please see our website: Electronic Common Technical Document (eCTD)

    For any questions regarding electronic submissions in general, please email CDER’s Electronic Submissions Support Team at [email protected] or call Valerie Gooding at 301-796-0902.

    Paper Submission Information

    Please submit 3 paper copies and a CD containing the submission to the following address:

    Food and Drug Administration
    Center for Drug Evaluation and Research
    Division of Antivirals 
    5901-B Ammendale Road
    Beltsville, MD 20705-1266
  • Note, if you don’t have activity information, but believe your product may have potential against the COVID-19 virus, you may find it useful to consult the National Institutes of Health, Division of Microbiology and Infectious diseases website (please see Preclinical and Clinical Services Contacts: Division of Microbiology and Infectious Diseases), which contains information about preliminary screening activities that may be available to potential sponsors of antiviral products. If you do not have specific information related to the COVID-19 virus, but still feel that your product warrants a PIND, then please include as much information as you can and a rationale for review.
  • Please also note the U.S. government has launched a website for stakeholders who wish to submit market research packages related to potential uses of products during the current outbreak: 2019 Novel Coronavirus (Medical Contermeasures.gov).

Any requests for product development for proposed COVID-19 uses and drug development should be sent to the COVID19-productdevelopment mailbox.

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