The U.S. Food and Drug Administration (FDA) has created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP). The program uses every available method to move new treatments for COVID-19 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…so that we gain valuable knowledge about their safety and effectiveness,” FDA said in an announcement about CTAP.
The resources include a CTAP Dashboard designed to provide a snapshot of development of potential COVID-19 therapeutics. FDA will update these numbers monthly. As of July 31, 2020, the snapshot is: 570+ drug development programs in planning stages, 270+ trials being reviewed by FDA, and two COVID-19 treatments currently authorized for emergency use. No other treatments have been approved by the agency for other use in COVID-19.
The CTAP resource package offers information of use to sponsors, including:
- Sponsors of therapeutics regulated by FDA’s Center for Drug Evaluation and Research (CDER) should send COVID-19 product development inquiries to COVID19firstname.lastname@example.org.
- Sponsors of therapeutics regulated by FDA’s Center for Biologics Evaluation and Research (CBER) should send COVID-19 product development inquiries to CBERProductJurisdiction@fda.hhs.gov. Additional information about CBER-regulated therapeutics and CTAP can be found at Coronavirus (COVID-19) | CBER-Regulated Biologics.
- Sponsors who are unsure of whether their drug is CDER- or CBER-regulated should make initial contact for COVID-19 drug development by contacting FDA at COVID19email@example.com.
- Medical devices do not fall within the CTAP program. Device sponsors should contact the Center for Devices and Radiological Health (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.
- As a general matter, if your product is already assigned to CBER or CDRH or you have been in contact with review staff at a center regarding your product, submission of additional inquiries or materials to the CTAP mailbox are not necessary and may result in unnecessary delays in processing your information.
FDA is accelerating the development and publication of guidances and other information for industry on developing COVID-19-related treatments. Key references include:
- Information and guidance on how to efficiently engage with FDA and expedite clinical trial initiation may be found at: Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency.
- General advice concerning the development of COVID-19 treatments may be found at: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.
- General advice concerning pre-Investigational New Drug meeting request content for COVID-19 treatments is provided at: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.
- Information on expediting quality assessments for products to treat COVID-19 patients and transferring manufacturing to new or alternative sites to avoid supply disruptions may be found at: COVID-19 Manufacturing, Supply Chain, and Drug Inspections.
- Information on pathways available for administering or studying the use of investigational COVID-19 convalescent plasma, including information for institutions interested in participating in the National Expanded Access Treatment Protocol, established through a collaborative effort by FDA and sponsored by the Mayo Clinic, can be found at: Recommendations for Investigational COVID-19 Convalescent Plasma.
- More information about the availability of COVID-19 treatments under an Emergency Use Authorization may be found at: FDA’s Emergency Use Authorization (EUA).
Edited by Michael Causey