FDA officials emphasize that without legislation from Congress, the OTC monograph program is not changing, and without a user fee program, the agency couldn’t implement changes.
FDA’s performance goals for potential OTC monograph user fees make four references to Congress. But an Aug. 23 webinar on the program’s details made it abundantly clear that Congress calls the shots on establishing the program.
The Center for Drug Evaluation and Research also was explicit during the 90-minute webinar that the program will not produce...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
