In the wake of 21st Century Cures legislation, next commissioner will have strong support across party lines to undertake smarter regulation aimed at improving the efficiency of the drug development process, former FDA head McClellan says.
Bipartisan support for the US FDA’s operations could help insulate it from adverse impacts in the current political climate, former agency commissioner Mark McClellan believes.
“Around many FDA issues there’s actually, I think, a pretty remarkable degree of bipartisan consensus about the right directions,” McClellan...
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.
