Regulatory Focus™ > News Articles > FDA Calls for Comments on Dispute Resolution System

FDA Calls for Comments on Dispute Resolution System

Posted 20 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is calling for public comment on its guidance for industry on formal dispute resolution, which covers scientific and procedural disputes occurring within FDA's Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER) that are unable to be resolved at the division level.

In the 20 March Federal Register posting, FDA said it was submitting its Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level to the Office of Management and Budget (OMB) for review.

 "The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented," wrote FDA.

"The guidance provides information on how the Agency will interpret and apply provisions of the existing regulations regarding internal Agency review of decisions (§ 10.75 (21 CFR 10.75), dispute resolution during the investigational new drug (IND) process (§ 312.48 (21 CFR 312.48)), and the new drug application/abbreviated new drug application (NDA/ANDA) process (§ 314.103(21 CFR 314.103))."

Comments are due 60 days after the date of the notice's publication.


Read more:

Federal Register - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Formal Dispute Resolution; Appeals Above Division Level


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