Monthly FDA Guidance and Regulatory News Review - September 2026
This September 2026 regulatory update focuses on FDA’s new guidance on neonatal parenteral nutrition compounding and blood component manufacturing, alongside draft guidance on evaluating hepatic impairment’s effects on drug pharmacokinetics and dosing. Key industry developments include evolving FDA and EMA policies on digital endpoints, alternative testing methods, expedited clinical trials, electronic product information, combination products, and biosimilar reviews. The FDA reported multiple drug and biologic approvals throughout September, including new molecular entities and new formulations, with the next Dermatologic and Ophthalmic Drugs Advisory Committee meeting scheduled for October 30, 2026.