43 Product-specific Guidances for Promoting Generic Competition

FDA has posted 43 product-specific guidances (26 new guidances and 17 revised guidances) that describe the agency’s current thinking and expectations on how to develop generic drug products. The new batch of documents is part of FDA’s strategy to promote generic drug development to address rising drug costs, according to an agency notice. Ten of the new draft guidances and six of the revised guidances are for complex drug products, including multiple products that don’t have generic competition. Also, three revised product-specific guidances are for abuse-deterrent formulations of opioid analgesics. “The documents issuing today add to the nearly 1,600 product-specific guidances we’ve published to date across therapeutic classes, ensuring our policies and standards keep pace with the evolving science of equivalence for generics, enabling greater patient access to high-quality, affordable medicines,” FDA commissioner Scott Gottlieb says.