New CDER Direct NextGen Collaboration Portal allows sponsors of complex ANDAs to submit and track formal meeting requests.
FDA eased the burden on sponsors to request a formal meeting for a complex ANDA, which conflicts with draft guidance, just as the new system debuted.
Agency officials unveiled a web portal for complex ANDA sponsors to make meeting requests. As of Oct. 1, the
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.
