The US Food and Drug Administration's proposed major reorganization for departmental review includes a change stripping complaint-handling responsibilities from the agency’s field organization, the Office of Regulatory Affairs.
US FDA's s Centers In Charge Of Complaint Handling In Major ORA Reorganization Plan
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.

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“It's kind of a free for all,” says longtime FDA funding advocate Steven Grossman. FDA knew funding it requested “was totally inadequate to the needs. So, Food Chemical Safety is stuck there with about six or eight other purposes the money could have been used for.
CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.
Supplements already under close scrutiny in the EU have been linked to severe adverse effects on the musculoskeletal system and liver, even at low doses.
UK industry association is offering online courses on subjects ranging from UK medicines regulations basics to deep dives on complex topics such as CBD.
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Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”
Supplements already under close scrutiny in the EU have been linked to severe adverse effects on the musculoskeletal system and liver, even at low doses.
Kyle Diamantas was a partner with the Jones Day firm when he was tabbed as acting deputy commissioner to lead the FDA’s Human Foods Program, established in the agency’s reorganization which became effective in October.