thinkpool

Examples of CTAP in Action

In an extraordinary surge to get a first wave of studies underway ―

• Immediately upon receipt, triaged requests from developers and scientists seeking to develop or evaluate new drug and biologic therapies, getting the right FDA staff in touch with them and the work to get studies going fast. With a first wave of requests behind us, FDA will generally respond within a day. 
• Provided ultra-rapid, interactive input on most development plans.  Interactions have generally been prioritized based on a product’s scientific merits, stage of development, and identification as a possible priority product in consensus USG documents.
• Provided ultra-rapid protocol review ？ within 24 hours of submission, in some cases.
• Completed review of single patient expanded access requests around-the-clock ？ and generally within 3 hours.
• Worked closely with applicants and other regulatory agencies to expedite quality assessments for products to treat COVID-19 patients and to transfer manufacturing to alternative or new sites to avoid supply disruption.

As of April 16, 2020, FDA received 950 inquiries and proposals concerning COVID-19 related drug development.  Because the overriding objective is to develop safe and effective treatments for American patients as soon as possible, the strongest proposals will go the front of the line on the basis of scientific merit.  We will post more detailed information concerning CTAP procedures and timelines on this webpage soon.

？