• 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 [email protected]. 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.

• By presenting a strong scientific rationale and supporting data showing that the therapy is appropriately safe to enter clinical trials and has the potential to be effective in patients.
• Start by taking full advantage of our pre-IND program. We have found that a complete pre-IND submission is the key to expediting comprehensive pre-IND advice, more rapid review of the subsequent IND and more rapid clinical trial initiation. Guidance regarding pre-IND meeting request content for COVID-19 drugs or biological products is at: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 related Drugs and Biological Products.
• General information on how to efficiently engage with FDA and expedite clinical trial initiation is at: Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency.
• Guidance concerning the development of drugs and biologics to treat and prevent COVID-19, including issues such as population, trial design, efficacy endpoints, safety considerations and statistical considerations, is at: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. Note that preventative vaccines and COVID-19 convalescent plasma are not within the scope of this guidance.  Recommendations concerning these products are addressed in separate guidance on Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry and Investigational COVID-19 Convalescent Plasma.
• Additional, detailed information is available at our CTAP website, at: Coronavirus Treatment Acceleration Program (CTAP).

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.