PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|January 28, 2016
FDA Seeking Feedback on Generic Drug Recommendations
Author(s)Pharmaceutical Technology Editors
The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.
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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
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