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 2026
The FDA has reminded more than 2,200 sponsors and researchers of their obligation to submit clinical trial results to ClinicalTrials.gov. The move aims to address ongoing gaps in reporting – particularly missing negative results – which can distort evidence on safety and efficacy and impact transparency in drug development. Read more
FDA reports progress on reducing animal testing in drug development
20 April 2026
The FDA has met its first-year targets under its roadmap to reduce animal testing in preclinical safety studies. The update highlights progress in adopting innovative, human-relevant methods, supporting the modernisation of drug development while maintaining safety standards. Read more
FDA advances real-time clinical trials with new pilots
23 April 2026
The FDA has taken further steps to implement real-time clinical trials, including launching two proof-of-concept studies that report data directly to the agency in real time. The FDA has also issued a request for information on a planned pilot programme, signalling broader adoption of real-time data approaches in clinical research. Read more
How do these changes affect you?
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