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Modernized GMPs

Executive Summary

FDA's Manufacturing Subcommittee of its Pharmaceutical Science Advisory Committee will discuss modernized good manufacturing practices for process validation on April 18-19. The subcommittee will also receive updates on International Conference on Harmonization quality guidelines Q8, Q9 and Q10 plus future ICH quality topics. The subcommittee will also discuss FDA's CMC Pilot Program and guidance. The meeting will be held at CDER's advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8:30 a.m. on both days...

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FDA manufacturing meeting cancelled

A meeting of the Manufacturing Subcommittee of FDA's Pharmaceutical Science Advisory Committee planned for April 18-19 has been cancelled by the agency. The subcommittee was to have discussed modernized good manufacturing practices for process validation; the chemistry, manufacturing and controls pilot program; and other issues (1"The Pink Sheet" Feb. 27, 2006, In Brief)...

Podcast: The Week In European Consumer Health Industry News, 8 March 2021

HBW editors Tom Gallen and David Ridley discuss the big issues in the European consumer health market from the past week. In this edition, they delve into probiotics, digital health and Bayer’s recent turnaround.

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