FDA Issues Complex Generics Guide, Gottlieb Frames As Drug-Pricing Move

FDA released draft guidance Monday (Oct. 2) aimed at facilitating development of one class of high-cost, widely sold complex drugs that currently lack generic competition. The agency also released guidance decoding complex generic-related Generic Drug User Fee Amendments (GDUFA) II commitments. The agency framed the release of these new guides as a part of the agency's generic competition plan. "We're undertaking a number of efforts to ensure that the pathways for approval for generic versions of complex drug products are...