FDA regulatory news highlights May 2026
From the press releases of the U.S Food and Drug Administration (FDA), Arex Advisor has selected the most important regulatory updates from the past month. FDA pilots one-day assessments to enhance inspection efficiency 6 May 2026The FDA has launched a pilot programme using one-day inspectional assessments to complement its standard inspection activities. The shorter, targeted […]
FDA regulatory news highlights April 2026
From the press releases of the U.S Food and Drug Administration (FDA), Arex Advisor has selected the most important regulatory updates from the past month. FDA urges sponsors to disclose missing clinical trial results 13 April 2026The FDA has reminded more than 2,200 sponsors and researchers of their obligation to submit clinical trial results to […]
FDA regulatory news highlights 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 FDA guidance aims to streamline biosimilar development and enable cost reductions 9 March 2026The FDA has issued draft guidance recommending reduced clinical pharmacokinetic testing for biosimilars where scientifically justified. […]
FDA regulatory news highlights February 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 artificial colors’ if […]
FDA regulatory news highlights January 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 and control requirements […]
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 […]