FDA Issues Draft Guides To Spur Development Of Complex Generic Drugs

FDA released a slate of guidance documents on Tuesday (Oct. 9) aimed at advancing development of complex generic drug products, which tend to be more difficult to formulate, manufacture and "genericize" than other generics, FDA Commissioner Scott Gottlieb said Tuesday. Two of the guidances detail how to design and conduct studies for various transdermal and topical delivery systems (TDS), and 25 are product-specific documents intended to help industry develop generic TDS products. The guidances released Tuesday build on FDA's efforts...