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CDER is committed to supporting the development of novel drugs, and the potential repurposing of existing therapies, to address the Coronavirus Disease 2019 (COVID-19) public health emergency. The Office of New Drugs (OND) within CDER is expediting this effort, working with potential drug sponsors to rapidly move products into clinical trials, while assuring that the trials are properly designed and are appropriately safe. The below information is intended to assist sponsors as they develop novel drug therapies.
Please note if you are developing a biological product regulated by CBER you should reach out directly to CBER at CBERProductJurisdiction@fda.hhs.gov. In addition, we have received a number of submissions regarding medical devices, which are regulated by CDRH. 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.
If you are not a sponsor and you are looking for general information on FDA’s coronavirus response, you can review materials provided on FDA’s website, including at Coronavirus Disease 2019 (COVID-19). FDA guidance regarding clinical trial conduct during the COVID-19 public health emergency may also be beneficial to broader audiences and is available at FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.
Background and General Information
OND oversight of an Investigational New Drug (IND) Application helps ensure that trials are conducted in a manner that protects subjects and advances our understanding of what therapies may help address the pandemic. OND recommends that drug development for COVID-19 related drugs be supported by randomized controlled trials, as this study design can generally provide the most definitive answer regarding whether the results observed in the trial are the result of the drug itself as opposed to other factors.
To facilitate development, we recommend seeking initial advice under a Pre-Investigational New Drug (pre-IND) meeting request for investigational uses, both of unapproved drugs, and FDA-approved drugs for which you seek an additional indication for the treatment or prevention of COVID-19. Submission of materials through a pre-IND meeting request helps ensure that discussions between OND and the sponsor proceed efficiently so that we can get promising therapies into studies quickly. To facilitate review, the pre-IND meeting request should include all relevant materials for the agency’s evaluation, including the meeting package, questions, and protocol. Following review of the pre-IND meeting request, FDA will work with the sponsor to help ensure that all necessary information has been submitted. Earlier and thorough review and discussion between the sponsor and FDA during the pre-IND meeting can lead to a more efficient and rapid review of the IND.
Please do not submit COVID-19 protocols to existing INDs. We have provided resources below for potential drug sponsors, including information regarding how to receive input on pre-IND meeting request content, and how to request divisional assignments for product development.
COVID-19 Drug Development Requests/Notifications Procedure
The COVID19email@example.com mailbox is used to track new submissions for the development of CDER-regulated drugs for COVID-19 use and ensure that they are sent to the appropriate review division. This mailbox is also available to address questions from sponsors of CDER-regulated drugs. Please note, sponsors of CBER-regulated drugs with questions about pre-IND meeting requests or office assignments should email CBER at CBERProductJurisdiction@fda.hhs.gov. Sponsors that are unsure of whether their drug is CDER- or CBER-regulated should make initial contact for COVID-19 drug development through COVID19firstname.lastname@example.org.
If applicants are able to submit a complete pre-IND meeting request for their product, we request that the submission be made through the portals and approaches described below. Pre-IND meeting requests for CDER-regulated drugs submitted through these portals and approaches are routed to the mailbox staff in a form and manner that facilitates tracking and rapid identification of division and office assignment, and may expedite trial initiation.
OND’s approach to therapeutic development in response to the COVID-19 pandemic is interdisciplinary and the central coordinating approach of the COVID-19 product development inbox helps to ensure the efficient involvement of all appropriate experts. Requests to the inbox will receive an acknowledgement within 1-2 days. Divisional review assignment will follow soon after.
Submission Content of Pre-IND Meeting Requests
OND has established a COVID-19 scientific/technical triage team to ensure the completeness and sufficiency of the information provided by sponsors for expedited review by review divisions. The triage team will communicate with sponsors, if necessary, on any additional information needed for divisional assignment and review. Once information is determined to be sufficiently complete, the triage team will communicate a division assignment to the sponsor and forward the submission to the OND review division for expedited review.
We ask that sponsors submit a complete pre-IND meeting request with their initial communication, as this will allow FDA to provide the most rapid feedback regarding your development plans and help get your products into clinical trials as soon as feasible. General advice regarding pre-IND meeting request content is provided at COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products, and advice about clinical development of COVID-19 drugs is provided at COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. Addressing the issues identified in the pre-IND meeting request guidance will facilitate efficient review of your request. During the review process for your pre-IND meeting request, the divisions or triage team may request additional information targeted to the specific drug and indication sought.
OND recommends that requests for divisional assignment and requests for initial feedback on new COVID-19 related drug development programs be sent to the COVID19-productdevelopment mailbox. If an initial request is sent directly to a review division, it will be immediately forwarded to the COVID19-productdevelopment mailbox for triage by the COVID-19 scientific/technical triage team mentioned above. However, once a COVID-19 development program has been assigned with a review division, subsequent communications should go directly to the assigned review division, not the COVID19-productdevelopment mailbox.
We have received a number of requests for Emergency Use Authorizations (EUAs) for either expanded use of approved products or introduction of unapproved therapies for COVID-19 to the market. Among other factors, authorization of products through this pathway rests upon an understanding of the potential risks and benefits of products for treatment of COVID-19. While we are encouraged to see the rapid development of potential therapies, in most cases, the effectiveness of novel or repurposed therapies is unknown. FDA cannot authorize an EUA without data supporting that the therapy’s known or suspected benefits outweigh known or suspected risks. Clinical trials provide the means through which novel therapies can be rigorously assessed to understand a product’s risks and benefits. If those trials demonstrate safety and effectiveness they will lead to drug approvals with those safe and effective approved products reaching widespread use. Accordingly, we encourage sponsors to submit a pre-IND meeting request, which will receive expedited review, rather than seeking EUAs for most therapies.
Sponsors developing CDER-regulated drugs for the treatment or prevention of COVID-19 have the following options for submitting their pre-IND meeting requests:
Option 1: Electronic Submissions Gateway (ESG)
Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic IND, NDA, ANDA or BLA regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. Please see Electronic Submissions Gateway for more information.
Option 2: CDER NextGen Portal
FDA CDER NextGen Portal is a website for users to report information to the FDA. Pre-assigned ANDA, NDA, BLA, IND, and MF number requests can be submitted via the CDER NextGen Portal. For assistance on registering, visit CDER NextGen Portal.
NOTE: If a sponsor obtains a pre-assigned IND number for a new COVID19 development program, that number should subsequently be listed on materials (e.g. pre-IND meeting request, etc.) the sponsor submits for that program. Information on requesting a pre-assigned application number visit Requesting a Pre-Assigned Application number.
Once a product has been assigned in accordance with the procedures described above, all future communications regarding that product should be directed to the responsible review office point of contact, or to your assigned regulatory project manager once your review team is established. If you have questions regarding a CBER assignment or submission requirements, please contact CBERProductJurisdiction@fda.hhs.gov. Complete Pre-IND meeting requests may be sent through the ESG portal described above. CBER pre-IND meeting requests that can’t be sent through ESG should be sent to CBERDCC_eMailSub@fda.hhs.gov.
- Center for Biologics Evaluation and Research (CBER)
- Center for Devices and Radiological Health (CDRH)
- Developing and Manufacturing Drugs Including Biologics
Research and Product Development Resources for researchers or sponsors not yet ready to initiate clinical trials
- Biomedical Advanced Research and Development Authority (BARDA)
- National Institutes of Health -National Institute of Allergy and Infectious Diseases
More information on Coronavirus Treatment Acceleration Program (CTAP)