Drug Development Questions And The FDA - The End Of The Black Hole

Commonly during drug development, significant issues arise for which FDA input is desired but that do not merit a full face-to-face multidisciplinary milestone meeting. In many cases, sponsors are reluctant to reach out to the FDA because of a concern that their questions will disappear into a black hole while the FDA focuses on PDUFA time-line mandated activities. The new FDA guidance, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, appears to provide some degree of certainty around the process for requesting this type of input and time frames for responses from the FDA. As described in the section of the guidance on Type C meetings, sponsors may request a written response to these types of questions and if the FDA agrees to answer the questions, the meeting granted letter will specify the date that the written responses are to be transmitted to the sponsor (provided that adequate briefing information is sent to the FDA in a timely manner). While the 75-day time frame for a response is probably not as quick as most sponsors would like, it does provide definition to a process that a company can plan around. As with all FDA interactions, we recommend taking the time to formulate the strategy which best aids in successful drug development, incorporating questions such as:

• Whether requesting a written response or a full meeting with the FDA provides the best strategic option for the sponsor; and
• How best to position questions and background materials so that written responses and/or meeting minutes from the Agency fully address and answer the sponsor’s questions.

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