FDA Releases Draft Guidance for Industry On Meetings to Improve Drug Development

The Food and Drug Administration released a draft guidance for industry on critical path innovation meetings (CIPMs) that are intended to improve efficiency and success in drug development, according to a notice published Oct. 8 in the Federal Register (79 Fed. Reg. 60,852).

CPIMs are a means by which the FDA’s Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, government and patient advocacy groups can discuss drug development, the agency said. The goals of CPIMs are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general ...