PharmaVOICE Blog Post

US FDA’s Coronavirus Treatment Acceleration Program (CTAP): Strategic Considerations for Investigational COVID-19 Drugs, Biologics, and Treatment Vaccines

Posted By: Dan Limbach
July 13, 2020

Click here to download printable PDF

The Coronavirus Treatment Acceleration Program (CTAP) is a special emergency program instituted by the US Food and Drug Administration (FDA) in response to the COVID-19 pandemic

  • The primary goal of the program is to expedite the availability of new treatments and vaccines to COVID-19 patients as rapidly as possible by using every possible resource, applicable pathway, and process across the agency
  • The program also ensures that the safety and effectiveness of these treatments and vaccines are simultaneously evaluated

CTAP Scope

CTAP covers COVID-19 programs for drugs and biologics, with the following exceptions noted by the Center for Biologics Evaluation and Research (CBER) as not covered:

  • Preventive vaccine programs
  • Any biologic/vaccine COVID-19 program for an investigational product which has been previously assigned to CBER for any other indication, and/or if there have been prior communications with CBER for the product

COVID-19 related device programs are not covered.

CTAP Status

  • CTAP is currently processing the second wave of COVID-19 treatment proposals and inquiries
  • As of April 16, 2020, CTAP had received 950 inquiries and proposals for the development of COVID-19 treatments
  • As of May 11, 2020, there were 144 active trials of COVID-19 treatments and 457 COVID-19 development programs in the planning stages
  • Turnaround time for CTAP requests is generally one day or less
  • CTAP protocol review times occur within 24 hours from submission for some cases

Single patient emergency/expanded access requests are being reviewed 24 hours a day and generally within three hours from request.

Click here to download printable PDF

About the Blog Poster: Dan Limbach

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