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 2026
The U.S. Food and Drug Administration has outlined a more flexible approach to chemistry, manufacturing and control requirements for cell and gene therapies. The approach is intended to support innovation and speed development, while helping sponsors align their development strategies ahead of Biologics License Application submissions. Read more
FDA promotes modern statistical methods for clinical trials
12 January 2026
The U.S. Food and Drug Administration has published draft guidance encouraging the use of Bayesian statistical methods in drug and biologics trials. The guidance aims to help developers make better use of available data, run more efficient studies, and support timely delivery of safe and effective treatments. Read more
FDA launches PreCheck pilot to boost US drug manufacturing
1 February 2026
The U.S. Food and Drug Administration has opened applications for its new PreCheck pilot programme, aimed at strengthening domestic pharmaceutical manufacturing. The initiative seeks to improve regulatory predictability, support the construction of US manufacturing sites, and streamline facility assessments ahead of specific product applications, helping reinforce the resilience of the US medicines supply chain. Read more
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