GAO says lack of clear information from FDA may influence whether manufacturers grant expanded access to investigational drugs; only two clinical holds have been due to adverse events from expanded access use.
The US Government Accountability Office (GAO) had only one recommendation for FDA after reviewing its expanded access program: the agency should clearly communicate how it uses adverse events data from the program in reviewing a drug for approval.
In a recent report, GAO said some manufacturers and other stakeholders contend that FDA is not clear about...
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.
