The agency tells former OOPD Director Tim Coté that it does not have the authority to consider the sponsor’s country of origin when determining whether to act on an application.
The US Food and Drug Administration concluded it does not have the authority to stop Russian companies’ application approvals and other actions because of the country’s invasion of Ukraine.
In a citizen petition response, the agency said that the FDA “is not directed to consider the country where...
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.
