President wants substantially more user fee revenue than negotiated in user fee agreements, and some in industry already are warning that requiring increases now could endanger program reauthorizations.
President Donald Trump's budget proposal could upend certainty about the user fee reauthorization process, and even if substantial changes are not enacted, the proposal threatens to create a substantial distraction for industry and FDA in the midst of other policy debates.
The blueprint released March 16 includes only a high-level look at his plans for the federal government, with a more...
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.
