Politics
The clinical and statistical review teams favored a complete response letter for the vasculitis treatment, while the review division and office directors supported approval.
“FDA’s proposed GRAS rule would move GRAS closer to the NDI model in at least one key respect, which is mandatory notification,” says attorney Ashish Talati. Proposed rule isn’t expected to require removal of ingredients available through self-GRAS processes.
Changing self-GRAS regulation, providing NDIN safety and identity guidance and modernizing supplement industry regulatory framework are on FDA’s “2026 priority deliverables,” but not requirement for public listing of all supplements available.
FDA Human Foods Program’s list notes Kennedy’s GRAS focus as first item in “Food Chemical Safety” category, saying the agency in 2026 “will publish a proposed regulation to require the submission to FDA of GRAS notices for all substances claimed to be GRAS.”
FDA updates pair of guidance documents relaxing its posture on how it regulates general wellness devices and clinical support software. Industry mostly welcomes changes, agreeing with agency’s view that lighter regulation will help spur innovation.
Consumer health product industry regulatory experts discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?
Industry trade group executives discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?
Seven new healthcare laws will be started in Germany 2026, and seven already underway – including the revamped KHAG hospital and DRGs reform law – will be completed. So goes the ministerial promise early in the new year. Medtechs signal further references to the so-far useful government dialog.
Commissioner Martin Makary told staff that more than 400 new people are being onboarded, although where they will be placed is unclear.
The announced deal means that of 17 companies the White House notified in July, only AbbVie and Regeneron have not yet made a deal.
HHS Secretary Kennedy says 2025-2030 guidelines “return us to the basics” and further his “Make America Healthy Again” campaign. CSPI says update “should have been based on high-quality scientific evidence, not trends, industry interests, or shifting cultural ‘wellness’ narratives.”
Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.