PhRMA on quality-by-design
Executive Summary
Industry views of quality-by-design and drug release/dissolution specifications will be presented at the Oct. 25-26 meeting of FDA's Advisory Committee on Pharmaceutical Science. The Pharmaceutical Research & Manufacturers of America and the Generic Pharmaceutical Association will present at the meeting, as will U.S. Pharmacopeia. The committee will also discuss quality-by-design topics of question-based review and alcohol-induced dose dumping. The meeting will be held at the CDER advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8 a.m. [Editor's Note: To 1watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...