FDA should clarify its criteria for rejecting generally recognized as safe notifications for food ingredients voluntarily submitted by companies, a consulting firm tells the agency.
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The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.
US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.
Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.
