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 2026
The FDA has issued draft guidance recommending reduced clinical pharmacokinetic testing for biosimilars where scientifically justified. The approach aims to lower development costs – potentially saving up to 50% of their PK studies costs – and accelerate timelines, supporting improved access to more affordable biologic medicines. Read more
FDA launches new platform to analyse adverse event data
11 March 2026
The FDA has introduced the FDA Adverse Event Monitoring System (AEMS), a unified platform for analysing adverse event reports across regulated products. The tool aims to modernise safety monitoring and improve transparency, supporting more efficient detection and assessment of potential safety signals. Read more
FDA explores alternatives to animal testing in drug development
18 March 2026
The FDA has issued draft guidance on the use of new approach methodologies (NAMs) as alternatives to animal testing in drug development. The guidance supports validation of human-relevant methods, aiming to accelerate development timelines while maintaining safety and effectiveness standards. Read more
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