New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.
FDA makes clear in its new internal policy on expanded access that while it will speed approval of applications, it cannot mandate a company to provide an investigational drug for a patient and will not even facilitate those discussions.
It serves as another reminder that FDA's role in the expanded access process is limited even as efforts to expand...
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.
