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…
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
The U.S. Food and Drug Administration conditionally approved Dectomax-CA1 (doramectin injection) injectable solution for the prevention and treatment of New World screwworm larval infestations, and prevention of NWS reinfestation for…
As part of the FDA’s broader strategy to combat the crisis of youth vaping, we are launching an initiative to increase voluntary compliance from retailers. Source: FDA Press Releases
Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow…
The U.S. Food and Drug Administration today announced that it has eliminated special safety requirements to monitor for serious heart rhythm problems in patients taking Caprelsa (vandetanib), an approved cancer…
The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by…
The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential…
The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Source: FDA Press…
The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the…