FDA
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FDA issues ‘largest-ever’ testing results for US infant formula
The regulator’s report also signaled that tighter oversight of the infant nutrition industry isn’t far behind.
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FDA takes steps toward real‑time clinical trials
The regulator said the goal is to speed up the development of promising therapies by addressing longstanding early-phase delays.
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CMS and FDA unveil a fast track for Medicare access to breakthrough devices
Initial reactions to the new regulatory pathway from medtech industry groups ranged from mostly positive to cautious.
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White House issues executive order to pave way for psychedelic drug treatments
The order, which surprised some legal analysts, will accelerate access to some Schedule I controlled substances to treat patients with serious mental illness.
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FDA to consider relaxing restrictions for peptides
The regulator said it is looking to take seven peptides off a restrictive list for unapproved drugs considered too risky.
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FDA targets companies marketing unapproved weight‑loss drugs online
The FDA’s latest round of warning letters points to an intensifying regulatory trend targeting companies marketing and selling GLP-1 and related compounds online.
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FDA seeks comments on expedited CNPV pilot program
The controversial Commissioner’s National Priorities Voucher program awards “ultra-fast” reviews for medications and biological products of strategic national importance while upholding the FDA’s standards.
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FDA launches unified adverse event reporting dashboard
In addition to consolidating adverse events for all regulated products, the new centralized platform will manage consumer complaints, regulatory misconduct reports, and whistleblower submissions.