A citizen petition asks FDA to refuse to approve any NDA seeking approval of a conventional Technetium-99m (Tc-99m) generator or Tc-99m product that r...
The National Advertising Division of BBB National Programs says Novartis should discontinue making certain claims in a direct-to-consumer ad for breas...
Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for medical devices related to the Covid19 public health emergency...
FDA accepts for review a Blueprint Medicines supplemental NDA for Ayvakit (avapritinib) for treating adults with indolent systemic mastocytosis.
FDA issues an immediately-in-effect guidance on compounding certain ibuprofen products that is intended to alleviated product shortages due to increas...
Federal Register notice: FDA classifies computerized behavioral therapy devices for treating symptoms of gastrointestinal conditions into Class 2 (spe...
Federal Register notice: FDA classifies intense pulsed light devices for managing dry eye into Class 2 (special controls).
A just-released FDA memo to commissioner Robert Califf and chief scientist Namandj Bumpus recommends that they order the withdrawal of Covis Pharmas M...
