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FDA Proposes Bioequivalence Research On Inhalers, Other Complex Drugs

Executive Summary

FDA is recommending specific research projects that will help demonstrate the bioequivalence of generic versions of complex branded products

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“Difficult” Bioequivalence Issues Make Limited Progress At Advisory Cmte.

If the July 23 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee is any indication, FDA appears years away from changing approval standards for generics of drugs with complex dosage forms.

“Difficult” Bioequivalence Issues Make Limited Progress At Advisory Cmte.

If the July 23 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee is any indication, FDA appears years away from changing approval standards for generics of drugs with complex dosage forms.

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