FDA has extended the comment period for its draft guidance that lays out flexible approaches for demonstrating effectiveness for certain new drugs and biologics, the agency announced Friday (Jan. 24). FDA granted the extension after the brand drug, biologics and regenerative medicine lobbies requested more time to weigh in. Comments on the draft are now due March 19. The agency published the draft guide, “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products,” last December to provide more...