FDA researchers say they found no difference in safety when patients were switched between interchangeable biosimilars and the reference biologic.
FDA warns Atlantis, FL-based Dr. Luis Pena-Hernandez about objectionable conditions in his work conducting a clinical investigation.
Biomic Sciences recalls all lots of ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray products due to microbial contamination concerns.
Attorney and data scientist Bradley Thompson blasts CDRH for its lengthy delays of up to 8,000 days in answering an average of 13 citizen petitions a ...
Federal Register notice: FDA provides notice that the courier address used for user fee payments has changed effective 10/6.
Federal Register notice: FDA announces that it revoked the Emergency Use Authorization issued to Becton, Dickinson for the BD Vacutainer Plus Citrate ...
Federal Register notice: FDA determines that Janssen Pharmaceuticals Ultram (tramadol hydrochloride) tablets, 50 mg, was not withdrawn from sale for s...
Moderna says it will start a Phase 3 trial of its investigational mRNA-1083 combination flu/Covid vaccine later this year.
