Archive for October 2025
FDA Acts to Protect Children from Unapproved Fluoride Drug Products
The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. Source: FDA Press Releases
Read MoreFDA Moves to Accelerate Biosimilar Development and Lower Drug Costs
The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that treat serious and chronic diseases. Source: FDA Press Releases
Read MoreFDA Issues Emergency Use Authorization for New World Screwworm Drug for Dogs
FDA issued an Emergency Use Authorization (EUA) concluding that based on the scientific evidence available, Credelio (lotilaner) chewable tablets may be effective in treating New World screwworm (NWS) infestations in dogs and puppies. Source: FDA Press Releases
Read MoreFDA Publishes Filing Checklists to Prevent Submission Delays
The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable. Source: FDA Press Releases
Read MoreFDA Awards First-Ever National Priority Vouchers to Nine Sponsors
The U.S. Food and Drug Administration today announced 9 voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. Source: FDA Press Releases
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