US FDA's response time and decision consistency on compliance issues should improve under reorganization that aims to take agency processes into the modern era. FDA is already moving forward on steps needed to implement the reorg as it awaits HHS and White House approval.
A majority of US Food and Drug Administration units – 15 out of its 21 offices – will be impacted by a pending reorganization that is currently awaiting clearance from higher ups in the Biden administration, outgoing principal deputy commissioner Janet Woodcock said on 19 January.
The reorganization, officially released in December 2023, has often been discussed as a revamp of the FDA’s food program and...
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.
