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In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA.
In addition, the draft guidance also states that although it strives to adhere to all established/estimated timelines, it is not always possible.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:
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)
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As stated in the FDA’s draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”
January 5, 2016
On December 9, 2015, the FDA released a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance attempts to promote timely,...
January 5, 2016
In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft...
January 6, 2016
Last month, FDA published a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance was published with the intention of...