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FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of th Source: FDA Press Releases
Read MoreLongtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA. Source: FDA Press Releases
Read MoreHHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
The U.S. Department of Health and Human Services (HHS) today announced historic action to restore gold-standard science to women’s health. Source: FDA Press Releases
Read MoreFDA Awards Second Batch of National Priority Vouchers
The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. Source: FDA Press Releases
Read MoreFDA Warns Companies Over Illegal Marketing of Botox and Related Products
The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. Source: FDA Press Releases
Read MoreFDA 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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