Through three-quarters of fiscal year 2023, CBER had hired nearly 70% of the mandated new PDUFA VII employees, while CDER had only hired 40%. The drug center also hired only 36% of the required new BsUFA III employees.
Recruitment campaigns by the Center for Biologics Evaluation and Research appear to be much more successful so far in fiscal year 2023 compared to the Center for Drug Evaluation and Research.
The US Food and Drug Administration’s drug and biologics groups are required in the 2022 prescription drug and biosimilar user...
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.
