FDA's proposed rule "Supplements and Other Changes to an Approved Application" and its accompanying guidance should be abandoned, the Pharmaceutical Research & Manufacturers of America asserted in Aug. 27 comments to the agency.

FDA is proposing to grant waivers of in vivo bioequivalence tests for certain immediate-release solid oral dosage form drugs that meet the characteristics of being highly permeable, soluble and having rapid dissolution.

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011