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FDA Nixes Innovator Industry-Backed Changes To Citizen Petition Rule

 
• By Brenda Sandburg

Agency rejects PhRMA requests to ease certification process and limit rule's application; separately, law firm Hyman, Phelps & McNamara objects to FDA practice of delaying ANDA approval announcements until it issues a petition decision.

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FDA’s final rule on citizen petitions makes only minor revisions to its proposed regulation, most notably shortening the agency’s response time from 180 days to 150 days.

The document instead is largely devoted to rejecting suggestions by the Pharmaceutical Research and Manufacturers of America to alter the scope of the regulation and its certification and verification requirements....

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