Obtaining IND-Related Feedback from FDA

January 6, 2016

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In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA.

In addition, the draft guidance also states that although it strives to adhere to all established/estimated timelines, it is not always possible.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

 

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As stated in the FDA’s draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”




General Regulatory Drug Approval

January 6, 2016

Four Benefits of Requesting an FDA Pre-IND Meeting

Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...

Read More
Agency Alerts General Regulatory

January 6, 2016

Best Practices for Meeting-Related Communication with 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In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA.  Among those included in the draft...

Read More
Agency Alerts General Regulatory

January 6, 2016

FDA Amends IND & Bioequivalence Regulations

On Monday, March 28th the FDA announced that it is amending its current IND and bioequivalence regulations. Specifically, FDA stated that it is changing “its regulations to update the address for...

Read More