Epstein Becker & Green attorney James Boiani believes Congress will step in to clarify that contrast agents should be regulated as drugs in the wake o...
FDA says that it is considering exercising enforcement discretion for N-acetyl-L-cysteine-containing products labeled as dietary supplements.
FDA approves a CartiHeal PMA for its Agili-C implant, indicated for treating an International Cartilage Repair Society (ICRS) Grade III or above knee-...
Attorney Kurt Karst says an FDA proposal to change the way generic drug exclusivity is awarded will result in fewer generic drugs coming to market.
FDA describes progress to date on its project to identify and prioritize pharmaceutical quality/chemistry, manufacturing, and controls (PQ/CMC) inform...
FDA approves Edwards Lifesciences Mitris Resilia valve, a tissue valve replacement specifically designed for the hearts mitral position.
FDA says Magellan Diagnostics is again distributing its LeadCare II blood test that had been part of a 2021 recall for a significant risk of falsely l...
FDA updates its guidance on materials to be submitted to support the issuance of an emergency use authorization for a Covid-19 vaccine.