FDA Quality Metrics Proposal Sparks Objections, Disarray

Pharmaceutical manufacturers argued FDA can’t make them report quality metrics data, but there was little else they could agree on in their initial reaction to the complex, enforceable reporting scheme FDA has proposed in its draft quality metrics guidance.

Industry’s anxieties about the pharmaceutical quality metrics guidance FDA drafted in July boiled over in an Aug. 24 meeting at FDA’s Silver Spring, Md., headquarters.

Groups for brand and generic drug makers, so often at odds in Washington, agreed on one point: FDA has no authority to make

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.