Trump Administration’s surprising call for increased user fees probably won’t have much impact on pending reauthorization process, but it does put on the table an important question for the biopharma industry to consider for the long term: should FDA be fully funded by user fees?
The user fee reauthorization process is off to a smooth start on Capitol Hill, with bipartisan agreement on the need to move the US FDA/industry agreement through quickly and without many controversial topics likely to get in the way.
Now if only FDA would get on board.
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.
