Under PDUFA V the FDA promotes innovation through enhanced communication between FDA and sponsors during drug development (see PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017 - PDF 130KB).
FDA’s philosophy is that timely interactive communication with sponsors during drug development is a core activity to help achieve our mission to facilitate the conduct of efficient and effective drug development programs, which can enhance public health by making new safe and effective drugs available to the American public in a timely manner.
Center for Biologics Evaluation and Research (CBER)
Enhanced communication contact information if your application is reviewed in CBER:
Please contact the Manufacturers Assistance and Technical Training Branch by phone at 1-800-835-4709 or 301-827-1800, or via e-mail at email@example.com.
Center for Drug Evaluation and Research (CDER)
The Regulatory Project Manager (RPM) is the primary contact for application-specific, technical, and scientific questions.
The RPM is a co-leader of the review team and has knowledge of the drug class, its history and related matters. The RPM is the primary resource to negotiate the timely resolution of technical, scientific, and regulatory questions, conflicts, or problems.
Please allow a reasonable amount of time for the RPM to respond to your contact attempts. If the RPM does not respond in a reasonable amount of time or within the expected timeframe for a regulatory submission, you should then follow-up with other review division management (e.g., Chief Project Management Staff first, then Deputy Division Director or Division Director, as needed).
The Enhanced Communication Team:
- Is a point of contact for general questions about the drug development process or for clarification on which review division to contact with questions. The information you are looking for may also be available on the FDA website.
- Is a secondary point of communication for sponsors who are encountering challenges in communicating with the review team for their IND. The Enhanced Communication Team assists in evaluating the issues to determine appropriate next steps, and then works with the review team and the sponsor to facilitate resolution.
- Identifies and disseminates best practices for enhanced communication.
You may contact the Enhanced Communication Team by emailing ONDCommunications@fda.hhs.gov. Please provide the following applicable information:
- Dates of the communications with the Review Division or Office
- The subject of the communication with the Review Division or Office
- Name of the Review Division or Office
- Application number
- Method of submission: email, phone, formal submission dated DD/MM/YYYY (include the names of those contacted by email or phone)