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 2025
FDA has urged manufacturers of nicotine pouches to adopt child-resistant packaging following rising reports of accidental exposure. Between April 2022 and March 2025, U.S. Poison Centers recorded a steady increase in such cases, with around 72% involving children under five years old. Read more
FDA introduces new evidence principles for rare disease drugs
3 September 2025
FDA has launched the Rare Disease Evidence Principles (RDEP) to provide clearer guidance on demonstrating effectiveness in therapies for rare diseases with small patient populations and high unmet need. The initiative aims to speed up development and improve predictability in the review of treatments, particularly for conditions linked to known genetic defects. Read more
FDA begins publishing complete response letters in real time
4 September 2025
FDA will now release complete response letters (CRLs) immediately after they are sent to sponsors. Alongside this policy change, the agency has also published 89 previously unreleased CRLs issued since 2024, outlining safety and efficacy deficiencies that prevented approval of pending or withdrawn applications. Read more
FDA creates import alert ‘green list’ for GLP-1 ingredients
5 September 2025
FDA has introduced a new import alert featuring a “green list” of verified sources for GLP-1 active pharmaceutical ingredients (APIs). The measure is designed to block illegal or unsafe GLP-1 APIs from unverified foreign suppliers, protecting patients and strengthening the security of the U.S. drug supply chain. Read more
FDA issues draft guidance to advance non-opioid pain treatments
10 September 2025
FDA has released draft guidance, Development of Non-Opioid Analgesics for Chronic Pain, aimed at supporting the development of safe and effective alternatives to opioids. The move forms part of the agency’s wider strategy to reduce opioid misuse while addressing the needs of the many U.S. adults living with chronic pain. Read more
FDA launches real-time reporting dashboard for cosmetics
12 September 2025
FDA has unveiled the FAERS Public Dashboard for Cosmetic Products, an interactive platform providing real-time access to adverse event data. The tool allows users to query, download, and analyse reports, which are updated daily with the latest submissions. Read more
FDA moves to update acetaminophen label on pregnancy risks
22 September 2025
FDA has begun the process of updating acetaminophen product labelling to include evidence of a possible link between use during pregnancy and an increased risk of neurodevelopmental conditions, including autism and ADHD, in children. Read more
FDA approves leucovorin calcium for cerebral folate deficiency
22 September 2025
FDA has authorised leucovorin calcium tablets for the treatment of cerebral folate deficiency (CFD), a rare neurological disorder linked to impaired folate transport into the brain. CFD is associated with developmental delays featuring autistic traits, seizures, and movement and coordination difficulties. Read more
FDA authorises first eyeglass lenses to slow childhood myopia
25 September 2025
FDA has authorised marketing of Essilor Stellest eyeglass lenses, designed to correct myopia with or without astigmatism and to slow disease progression in children aged 6 to 12 at the start of treatment. Read more
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