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 2026
The FDA has launched a pilot programme using one-day inspectional assessments to complement its standard inspection activities. The shorter, targeted reviews are designed to improve the efficiency of regulatory oversight and help the agency focus inspection resources more effectively while maintaining compliance monitoring. Read more
FDA issues guidance to strengthen pregnancy safety data collection
8 May 2026
The FDA has published final guidance on post-approval pregnancy safety studies for drugs and biologics. The recommendations outline methodologies that can be used to generate more robust safety data during pregnancy, helping improve the quality of information available to support treatment decisions for pregnant patients. Read more
FDA seeks input on drug repurposing to address unmet medical needs
11 May 2026
The FDA is seeking stakeholder input on efforts to expand drug repurposing, including identifying new indications and patient populations for already approved medicines. The initiative aims to accelerate access to treatments by building on existing safety and efficacy knowledge, while also supporting updates to product labelling to ensure information remains clinically relevant and scientifically current. Read more
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