CBER’s Document Control Center (DCC) will not process any submissions received by mail or courier including submissions provided on paper and electronic media (e.g., CDs, USB drives) until further notice. Submissions may be sent through the Electronic Submission Gateway or in some cases by e-mail. Please see the Letter to CBER Sponsors, Applicants and Regulated Entities.
The mission of the FDA’s Center for Biologics Evaluation and Research (CBER) is to protect and promote the public health, in part by ensuring the safety and efficacy of the products we regulate. This includes biological products such as prophylactic and therapeutic vaccines, whole blood and blood products, cellular products and exosomal preparations, gene therapies, tissue products and live biotherapeutic agents. CBER also regulates selected drugs and devices used in the testing and/or manufacture of our biological products. In keeping with that mission CBER uses every tool available to help patients access promising biological products while facilitating research to evaluate their safety and efficacy as well as manufacturing efforts.
CBER is working on multiple fronts to address the COVID-19 pandemic such as:
- Expediting clinical trials for preventive vaccines and other therapeutic biological products that hold promise to prevent or treat COVID-19 by providing timely advice and interactions
- Supporting product development and scaling up of manufacturing capacity for high priority products for COVID-19
- Helping to ensure an adequate blood supply in light of reduced blood donations due to social distancing and the cancellation of blood drives
- Facilitating access to convalescent plasma and other investigational products for patients with COVID-19, including through collaborations with the private and public sectors to establish the National Expanded Access Treatment Protocol that can be widely used
- Providing information to healthcare providers and researchers to help them submit emergency IND requests to use investigational products for patients with COVID-19
If you are developing or interested in developing a CBER-regulated product to treat or prevent COVID-19, including a vaccine, cellular product, or blood-derived product, this page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.
CBER is making every effort to review all regulatory submissions (e.g., requests for pre-investigational new drug application (IND) meetings, INDs, and emergency use authorizations (EUAs)) for COVID-19 related treatments as quickly as possible. In order to facilitate this rapid review, please ensure that regulatory submissions contain all of the information necessary to perform a complete review and are submitted in accordance with all regulatory requirements.
Agency review staff are prioritizing review of regulatory submissions based on a variety of factors including completeness of the submission, scientific merit, and stage of development. Although CBER is taking an all hands on deck approach to process and review regulatory submissions with the urgency warranted by this pandemic, due to the large volume of submissions and inquiries, once your product has been assigned to CBER, it may take up to one week for the appropriate review office to notify you that your submission has been received and, if applicable, rapid review has commenced.
This webpage provides additional resources to help you determine the next best steps for engaging with CBER, including what regulatory submission is appropriate, what to include in that submission, and how to submit it.
If you are not a product developer and are looking for general information on FDA and coronavirus response efforts, you can review materials provided on FDA’s COVID-19 website. FDA has also published resources for patients about COVID-19, including Questions and Answers for Patients About Clinical Trials.
If you are developing a CBER-regulated product and have questions, CBER’s Division of Manufacturers Assistance and Training in the Office of Communication, Outreach and Development (Industry.Biologics@fda.hhs.gov, 240-402-8010, or 800-835-4709) can provide additional information or answers to questions that can help you prepare your submission and ensure that it contains the necessary information to facilitate review.
If you are uncertain about CBER center or office assignment for your product, please contact: CBERProductJurisdiction@fda.hhs.gov
CBER-regulated therapeutic products fall within FDA’s Coronavirus Treatment Acceleration Program (CTAP). Please note that for products under CBER’s jurisdiction, submission to the CTAP mailbox helps to facilitate identification and assignment to the appropriate review office within our Center so that your inquiry gets to the right subject matter experts quickly. Although we are working diligently to expedite the development of multiple promising vaccine candidates to the greatest extent possible, preventive vaccines are not included within CTAP and submissions or inquiries regarding preventive vaccines should not be submitted to the CTAP mailbox.
As a general matter, if your product is already assigned to CBER for another intended use or you have been in contact with CBER staff regarding your CBER-regulated product, please do not submit any additional inquiries or materials to the CTAP mailbox. Such submissions are not necessary and may result in unnecessary delays in processing your information. Once a product has been assigned to a CBER office, all future communications regarding that product should be directed to the responsible review office point of contact, or, once your review team is established, to your assigned regulatory project manager.
Do not submit regulatory documents (e.g., pre-INDs, INDs, emergency IND, or EUAs) for CBER-regulated products to the CTAP Mailbox. Instructions for these submissions are provided below.
In particular, in the case of emergency single patient INDs (eINDs) for all CBER-regulated products other than convalescent plasma, please call 240-402-8010 or 800-835-4709 or email firstname.lastname@example.org. After working hours, call FDA's Office of Emergency Operations at 1-866-300-4374 or 301-796-8240. For information on the process for submitting eINDs for convalescent plasma, please see Recommendations for Investigational COVID-19 Convalescent Plasma. Failure to follow these processes may delay review of your eIND and possibly delay access for your patient.
For unapproved products, please note that your product may not be distributed for clinical use in humans until there is an IND in effect.
One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19. The Recommendations for Investigational COVID-19 Convalescent Plasma page provides information on the pathways available for administering or studying the use of COVID-19 convalescent plasma, including an investigational new drug application (IND) under the traditional IND regulatory pathway, an expanded access IND, or a single-patient emergency investigational new drug application (eIND). As part of its efforts to help facilitate the collection and development of convalescent plasma, FDA has led a collaborative effort to establish the National Expanded Access Treatment Protocol (held by Mayo Clinic) to help provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place.
Please note that FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma. Health care providers or acute care facilities should obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.
Individuals who have fully recovered from COVID-19 may be able to help patients currently fighting the infection by donating your plasma. Please visit this webpage for information.
CBER’s webpage has information about the regulatory framework for products regulated by CBER, including the Center’s policies, procedures, and review resources that may be helpful in answering questions you have about developing a CBER-regulated product.
CBER has provided information for sponsors, applicants and regulated entities on steps the Center has taken to prioritize work that advances the nation’s response to the COVID-19 pandemic. These steps seek to address the impact of the public health emergency on day-to-day operations in CBER and industry, while ensuring that government and private sector response efforts receive the highest priority.
Important information provided to sponsors includes:
- Processing of Incoming Documents
- Conduct of Clinical Trials involving Medical Products
- Postmarket and Compliance Activities
Details about each of these topics and more can be found in the letter posted on CBER’s website.
Emergency Use Authorization
Under an Emergency Use Authorization, the FDA Commissioner may permit the use of unapproved medical products or unapproved uses of approved medical products in certain emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives. We encourage applicants to submit any questions to CBEREUA@fda.hhs.gov.
COVID-19 Related Guidance Documents
FDA has issued several guidance documents related to COVID-19, including several that are immediately in effect. For the latest information, please see the FDA’s COVID-19 Related Guidance Documents web page.
Additional FDA Resources
All FDA Centers are working together to help bring new products for COVID-19 to the American people. Sponsors who want to develop drugs, medical devices or diagnostics related to COVID-19 can visit the following web pages:
- COVID-19 Resources for Healthcare Professionals
- Center for Drug Evaluation and Research: Coronavirus (COVID-19) | Drugs
- Center for Devices and Radiological Health: Coronavirus (COVID-19) and Medical Devices
- FDA’s Coronavirus Disease 2019 (COVID-19) web page