Firms could find themselves charged multiple US generic drug user fees if affiliates are not identified and ANDAs claimed.
FDA is approaching 10,000 approved abbreviated new drug applications in its database, but has not verified the owner of nearly 29% of them as it moves closer to beginning calculations of new generic drug user fees.
An updated list of the owners of all approved ANDAs found more than 2,800 that were classified as "unclaimed" as...
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.
