What to do if you experience delays in obtaining IND-related feedback from the FDA:
In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA.
In addition, the draft guidance also states that although it strives to adhere to all established/estimated timelines, it is not always possible. If sponsors experience delays in obtaining the FDA’s responses, the document provides a recommended approach. This approach should be taken sequentially and is as follows:
- Contact the appropriate FDA project manager, typically the review division RPM, for a status update after the expected amount of time (e.g., the timelines described in a MAPP) for FDA response has passed;
OR
Contact the appropriate FDA project manager, typically the review division RPM, for a status update after the estimated response time has passed (i.e., the estimated FDA-response date communicated to the sponsor previously)
- Contact the appropriate FDA project manager’s next level supervisor for assistance in eliciting a response from the project manager
- Contact the appropriate division or office management officials for assistance in eliciting a response from the project manager
- Contact CDER’s ECT or CBER’s Ombudsman for assistance in eliciting a response from the project manager
For more information on FDA recommendations for IND-related communication, view our FDA News article here.
As stated in the FDA’s draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”
