Monthly FDA Guidance and Regulatory News Review - August 2026
This August 2026 regulatory update focuses on the FDA finalizing three guidances addressing formal sponsor meetings, cell and gene therapy development, and therapeutic-equivalence evaluations, while issuing draft guidance on container-closure systems, ANDA versus 505(b)(2) applications, and immunotherapy potency assessments. August RAPS regulatory news focused on manufacturing and quality oversight, quantitative medicine, CMC digitization, reduced animal testing, rare-disease evidence, regulatory pathways, and GMP compliance. FDA also approved 11 products, including five priority-reviewed new molecular entities. Finally, Vaccines Advisory Committee meeting is scheduled for 01Oct26.