FDA regulatory news highlights March 2026
8 April 2026 From the press releases of the U.S Food and Drug Administration (FDA), Arex Advisor has rounded up a selection of regulatory highlights from the past month. FDA guidance aims to streamline biosimilar development and enable cost reductions 9 March 2026The FDA has issued draft guidance recommending reduced clinical pharmacokinetic testing for biosimilars […]
FDA regulatory news highlights February 2026
5 March 2026 From the press releases of the U.S Food and Drug Administration (FDA), Arex Advisor has rounded up a selection of regulatory highlights from the past month. FDA revises policy on ‘no artificial colors’ claims 5 February 2026The FDA has introduced a new approach allowing food companies to label products as containing ‘no […]
FDA regulatory news highlights January 2026
5 February 2026 From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of regulatory highlights from the past month. FDA signals flexible CMC oversight for cell and gene therapies 11 January 2026The U.S. Food and Drug Administration has outlined a more flexible approach to chemistry, manufacturing […]
FDA regulatory news highlights November 2025
5 December 2025 From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of regulatory highlights from November 2025. FDA Awards Second Batch of National Priority Vouchers 6 November 2025The FDA has awarded six additional vouchers under its Commissioner’s National Priority Voucher pilot, bringing the total to […]
FDA news highlights October 2025
6 November 2025 From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of highlights from October 2025. FDA awards first-ever National Priority Vouchers to nine sponsors 16 October 2025The Food and Drug Administration (FDA) has announced the first recipients of its new Commissioner’s National Priority Voucher […]
FDA news highlights September 2025
30 September 2025 From the press releases of the U.S Food and Drug Administration, Arex Advisor has rounded up a selection of highlights from September 2025. FDA calls for child-resistant packaging of nicotine pouches 2 September 2025FDA has urged manufacturers of nicotine pouches to adopt child-resistant packaging following rising reports of accidental exposure. Between April […]