Obtaining IND-Related Feedback from FDA

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In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA.

In addition, the draft guidance also states that although it strives to adhere to all established/estimated timelines, it is not always possible.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:

1. 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)

2. Contact the appropriate FDA project manager’s next level supervisor for assistance in eliciting a response from the project manager
3. Contact the appropriate division or office management officials for assistance in eliciting a response from the project manager
4. 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As stated in the FDA’s draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”