FDA : Coronavirus Treatment Acceleration Program (CTAP)

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FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness.

Snapshot for Developing Therapeutics

Given the urgent nature of the pandemic and the number of companies and researchers developing COVID-19 related therapies, the following numbers may change frequently. As of May 11, 2020, the snapshot is:

  • 144 active trials of therapeutic agents
  • Another 457 development programs for therapeutic agents in the planning stages

Sponsors of CDER-regulated drugs may find information on drug development programs and requesting feedback through the Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency landing page.

Sponsors of CBER-regulated drugs may find information on development and receiving feedback at the Coronvarirus (COVID 19) | CBER-Regulated Drugs landing page.

Sponsors that are unsure of whether their drug is CDER- or CBER-regulated should make initial contact for COVID-19 drug development by contacting FDA at COVID19-productdevelopment@fda.hhs.gov.

Please note we have received a number of submissions regarding medical devices to the COVID19-productdevelopment@fda.hhs.gov mailbox. CDRH requests are not within the scope of the CTAP program, and we encourage device sponsors to contact CDRH directly at CDRH-EUA-Templates@fda.hhs.gov for in vitro diagnostics (IVDs) and CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov for non-IVD medical devices.

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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.

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Support for CTAP

  • Redeployed medical and regulatory staff to review teams dedicated to COVID-19 therapies.
  • Involved senior management in review of submissions.
  • Redeployed medical, operations, and policy staff to support the overall effort.
  • Streamlined processes and operations for developers and scientists to send us inquiries and requests.
  • Provided resources to healthcare providers and researchers to help them submit emergency requests to use investigational products for patients with COVID-19 infections.

Related Resource

National Institutes of Health Press Release: NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options

We will continue to enhance and expand CTAP. To the extent permitted by confidentiality laws, we’ll post summary statistics, keep the public updated, and link to public information about ongoing clinical trials and to summaries of drugs in clinical and preclinical development.

Continue at:  https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap

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