Additional hiring in FDA’s FY 2022 budget request also is expected to help address the inspections delayed by the coronavirus pandemic.
The US Food and Drug Administration’s drug manufacturing facility inspections are expected to dramatically increase in fiscal year 2022 to more normal levels, but additional funding may be necessary to combat the backlog caused by the coronavirus pandemic.
COVID-related restrictions nearly ground the entire inspection program to a halt in the second half of FY 2020 and most...
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.
