Watson (now Teva) and InvaGen (now Cipla) failed to submit new bioequivalence data following enforcement action against Cetero Research.
After a six year effort, the US Food and Drug Administration has run out of patience with Watson Laboratories Inc. and InvaGen Pharmaceuticals Inc. and is moving to withdraw approval of two of their abbreviated new drug applications because the firms failed to conduct additional bioequivalence studies for the products.
The companies' ANDAs were supported by bioequivalence studies conducted by Cetero Research, the contract research organization that the agency concluded...
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.
