Conditional Approval Proposals for FDA: Current Context and Potential Ramifications
By EsqSocial Corporation 01/05/25
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders across the industry. In light of recent remarks from the FDA commissioner on the development of a new conditional approval pathway, we revisit FDA’s existing approval standard and the broader regulatory and policy context that has, to date, underpinned FDA’s drug approval...
By: Morgan Lewis - As Prescribed