In response to the novel coronavirus (COVID-19), FDA quickly created in March 2020 the Coronavirus Treatment Acceleration Program (CTAP), which was designed to help facilitate the development of drugs and biologics (other than vaccines) for COVID-19 therapeutics. CTAP enabled CDER and CBER to leverage cross-agency scientific resources and expertise for COVID-19 therapeutic development and review and provide extensive guidance and information to companies, researchers, patients, and consumers. CTAP helped FDA achieve numerous critical milestones in the COVID-19 response. In the three years since CTAP’s beginning, there have been several hundred development programs and clinical trials reviewed by FDA for COVID-19 therapeutics, and numerous available treatments that were authorized for emergency use or approved by FDA for use in COVID-19.
The development of COVID-19 therapeutics that are effective against current and future variants remains a critical priority. CTAP today remains vital to the expedited development of COVID-19 therapeutics, particularly for programs that are intended to address an unmet medical need. Using available regulatory mechanisms, CTAP strives to facilitate access to safe, effective, and high-quality treatments for COVID-19. CTAP is leveraging the agency’s scientific experience and knowledge of COVID-19 to support current and future clinical trials testing new treatments for COVID-19. From these efforts, we continue to gain valuable knowledge about the safety and effectiveness of potential therapies for COVID-19.
For a list of approved COVID-19 therapeutics, please visit our Coronavirus (COVID-19) Drugs webpage and view the “Approved Drugs” section under COVID-19 Therapeutics.
Existing emergency use authorizations (EUAs) for products may remain in effect and the agency can issue new EUAs if the situation meets the criteria to do so. CDER’s EUA webpage contains products authorized for COVID-19.
We understand companies, researchers, patients, and consumers need timely information on therapeutic development for COVID-19. Below are key resources for researchers and therapeutic developers, and patients and consumers.
FDA has published guidance documents and other information for industry on developing COVID-19-related treatments. Key references include:
- General advice concerning the development of COVID-19 treatments may be found at: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- Recommendations on the generation of data to support an emergency use authorization (EUA) for monoclonal antibody products targeting SARS-CoV-2 can be found at: Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency
- More information about the availability of COVID-19 treatments under an Emergency Use Authorization may be found at: FDA’s Emergency Use Authorization (EUA)
- If your product is already assigned to CBER, CDRH, or a specific review division in CDER you should reach out to the Regulatory Project Manager (RPM) assigned to your application for specific questions associated with your product development program.
- Sponsors of potential new COVID-19 therapies who are unsure of whether their product is CDER- or CBER-regulated may contact FDA at firstname.lastname@example.org.
- Sponsors of potential new COVID-19 therapies regulated by CDER who have general questions about COVID-19 product development but are uncertain which division their inquiries would go to may reach out to ONDCommunications@fda.hhs.gov.
- Sponsors of CBER regulated therapeutics 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
- Medical devices do not fall within the CTAP program. Device sponsors should 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
CTAP’s primary goal is to continue to prioritize the development of COVID-19 therapeutics for patients and consumers, particularly for programs that are intended to address an unmet medical need. Here are a number of resources that may be of interest to patients and consumers:
- More information on how FDA ensures the safety of patients in COVID-19 clinical trials may be found at: Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19
- Clearly understandable explanations of key technical terms are at: Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19
We believe that transparency about CDER’s and CBER’s review of the scientific information supporting their recommendations to issue Emergency Use Authorizations (EUAs) for drugs or biological products promotes public confidence in FDA’s scientific review process and ultimately in using the authorized products appropriately.
Therefore, our goal is to be as transparent as possible about the scientific basis for recommending that a drug or biological product be authorized for emergency use under section 564 of the Federal Food, Drug and Cosmetic Act (FD&C Act) or be revised or revoked.
- When a CDER-regulated or CBER-regulated product is authorized for emergency use, we intend to the extent appropriate and permitted by law to make public the Center’s review of the scientific data and information supporting our recommendation to issue the EUA.
- When an EUA is revised, we also intend to make public the Center’s review of the scientific data and information supporting our recommendations to revise the EUA.
Consistent with our authority under section 564(h) of the FD&C Act, our goal is to disclose information from our EUA review documents as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals. We may redact certain information that is exempt from disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. sec. 552, such as trade secrets or other information identified by the EUA requestors that is exempt under FOIA. The redacted information may vary depending on the type of data contained in the reviews and whether the requestor consents to the release of information that is exempt under FOIA.