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  • December 20, 2019

SILVER SPRING, MD—In November, the FDA published 105 product-specific guidances (PSGs), which provide recommendations for developing generic drugs and generating the evidence needed to support ANDA approval. The published guidances include revisions of previous PSGs as well as new guidances for complex products, products with no currently approved ANDAs, and complex and non-complex NCEs. The new batch brings the total number of PSGs to more than 1,750.