Agency proposal, now under HHS review, further reduces chances of losing another whistleblower complaint by taking ORA out of the loop, while proposing a new name for its slimmed-down field organization: Office of Inspections and Investigations. Meanwhile, an agency veteran, Michael Rogers, will lead the revamped organization as associate commissioner.
no more complaints for ora/oii • Source: Shutterstock
A major reorganization that the Food and Drug Administration proposed 13 December for departmental review includes a new change stripping complaint-handling responsibilities from the agency’s field organization, the Office of Regulatory Affairs.
Sparked by a lost whistleblower complaint, the revamping of the agency’s Human Foods Program and field operation makes both the...
Learn what's happening at the US FDA. On the go.
Derrick Gingery and the team bring you a weekly "Drug Fix".
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.