Posted by Michael Wonder on 20 Jul 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
20 July 2018 - The U.S. FDA 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 finalised, 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.
Ten of the new draft guidances and six of the revised guidances are for complex drug products, including multiple products that don’t yet have generic competition. This batch of guidances also includes three revised product-specific guidances for abuse-deterrent formulations of opioid analgesics.
