Curious comment by president could place US FDA Commissioner in tough spot balancing his boss' priorities with his and staff's concerns about pending right-to-try legislation.
President Trump has put FDA Commissioner Scott Gottlieb at the front of his push to pass right-to-try legislation, whether Gottlieb wanted to be there or not.
During a Feb. 1 speech to a retreat for Republican lawmakers, Trump continued his push for legislation that would expand...
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.
