Month: October 2025

Major regulatory breakthrough: FDA moves to make biologic drugs more affordable The FDA has unveiled draft guidance to dramatically accelerate biosimilar development — lower-cost alternatives to high-priced biologic medicines. Though biologics represent only ~5% of prescriptions, they account for over half of all U.S. drug spending.The new framework proposes removing the traditional requirement for large,… Continue reading Major regulatory breakthrough: FDA moves to make biologic drugs more affordable

🚀 FDA Opens the Black Box: Filing Checklists Now Public to Reduce Delays The FDA has taken a bold step toward greater transparency and efficiency by publishing the internal filing checklists used by the Center for Drug Evaluation and Research (CDER).These checklists—now part of CDER’s Good Review Practices: Refuse to File (MAPP 6025.4)—give sponsors a… Continue reading 🚀 FDA Opens the Black Box: Filing Checklists Now Public to Reduce Delays

FDA launches new fast-track incentive for national health priorities Big move from the FDA — it awarded the first-ever Commissioner’s National Priority Vouchers (CNPVs) to nine drug sponsors. This new initiative fast-tracks review for therapies that tackle urgent health needs or strengthen U.S. drug manufacturing capacity. The selected products span critical areas such as Type… Continue reading FDA launches new fast-track incentive for national health priorities