Tuesday, July 24, 2012

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting [Committee Meeting August 8, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)] Agenda: During the first session, the committee will discuss the uses and limitations of in vitro dissolution testing and propose future direction for evaluation including possible research. During the second session, the committee will receive an update on the FDA’s recently posted draft guidances for industry on biosimilar products. This will be an awareness topic and there will not be formal Committee discussion or recommendation.

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