Friday, July 20, 2018

FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids

The U.S. Food and Drug Administration today announced a new batch of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe the FDA’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their respective reference-listed drugs.

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