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CDER ADVISORY COMMITTEE TO MEET IN OCTOBER

August 23, 2006

CDER has announced that its Advisory Committee for Pharmaceutical Science will hold a public meeting Oct. 5 and 6 in the agency's building at 5630 Fishers Lane, Rockville, Md.

On the agenda Oct. 5 will be an update from the International Conference on Harmonisation Quality Topics and presentations from the FDA's Office of Pharmaceutical Science, the Generic Pharmaceutical Association and PhRMA on quality-by-design initiatives.

The Oct. 6 session will include presentations on: risk management for complex pharmaceuticals; bioequivalence issues pertaining to highly variable drugs; current thinking on issues and definitions pertaining to nanotechnology; definitions for topical dosage forms; and the Critical Path Initiative.

The website of the Advisory Committee for Pharmaceutical Science can be found at www.fda.gov/cder/OPS/OPS_AdvisoryComm.htm (http://www.fda.gov/cder/OPS/OPS_AdvisoryComm.htm).