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The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.
FDA is looking for feedback on 47 product-specific recommendations for developing generic drugs therapeutically equivalent to specific reference-listed drugs. FDA has published the recommendations as part of the agency’s goal to facilitate generic drug availability and assist generic-drug companies in identifying methods for developing drugs and generating evidence needed to support abbreviated new drug application (ANDA) approval.
A complete list of the new and revised bioequivalence recommendations can be found on FDA’s website. FDA is asking for comments to be submitted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015.