Major achievements of latest drug user fee agreement include focus on drug development cycle, more review time and pilot programs, FDA and industry reps tell DIA meeting.
For FDA, the sixth authorization of the Prescription Drug User Fee Agreement (PDUFA VI) marks a positive shift in the relationship between the agency and industry.
"When I think about PDUFA V and then into PDUFA VI the theme I feel like we've engaged in is...
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.
