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  5. Coronavirus Treatment Acceleration Program (CTAP) Frequently Asked Questions
  1. Coronavirus (COVID-19) | Drugs

Coronavirus Treatment Acceleration Program (CTAP) Frequently Asked Questions

  • We check the CTAP inbox several times daily. 
  • One key factor on which FDA prioritizes inquiries regarding potential COVID-19 therapeutics is the completeness of the information provided. 
  • An inquiry with a scientific rationale and supporting evidence generally advances more rapidly than a preliminary, not yet fully formed inquiry. 
  • Assume that FDA is reviewing your substantive response thoroughly in order to provide you with meaningful feedback.
  • Double check to make sure you completely answered FDA’s questions to you.
  • If your inquiry has been assigned to a Regulatory Project Manager (RPM) for a review team, ask the RPM about your inquiry’s status. 
  • If your inquiry has not yet been assigned to a review team, send a status inquiry to the COVID-19 email inbox at COVID19-productdevelopment@fda.hhs.gov. We have a team in place whose job is to make sure you get connected with the right person.
  • If your product has been assigned to CBER, please do not submit additional inquiries or materials to the COVID-19 email inbox.  This may delay FDA’s response.  All future communications regarding that product should be directed to the responsible CBER review office point of contact, or, once your review team is established, to the assigned CBER Regulatory Project Manager.

Consistent with confidentiality restrictions, we report monthly on:

  • Approximate number of therapeutic development programs in the planning stages (i.e., active pre-IND programs),
  • Approximate number of studies reviewed (i.e., safe-to-proceed INDs),
  • Approximate number of studies by treatment type,
  • Approximate number of studies by early or late stage,
  • Emergency use authorizations and
  • NDA and BLA approvals.

This information is available on the CTAP webpage.

  • While the FDA is part of a whole of government approach to COVID-19, CTAP is a distinct component of this effort focusing specifically on therapeutics, not vaccines or devices.
  • Another major initiative of the U.S. government, Operation Warp Speed, funds and rapidly develops or co-develops vaccines, therapeutics and diagnostics, while the FDA, through CTAP, regulates therapeutic development.  Additional information about OWS is available at Fact Sheet: Explaining Operation Warp Speed.
  • There is a clear delineation between OWS executive actions and FDA regulatory decision making.
  • FDA’s regulatory decision making is independent from the Biomedical Advanced Research and Development Authority (BARDA) or Operation Warp Speed funding decisions and based on our statutory and regulatory standards.
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