FDA plans to discuss 1/26 a new strategy to annually select Covid-19 strains in June for immunizations beginning no later than September each year.
FDA issues its long-awaited final guidance entitled Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance fo...
Johnson & Johnsons DePuy Synthes medical device unit agrees to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kic...
A citizen petition by Soft Lights Foundation urges FDA to issue regulations under 21 CFR Part 1040.41 to regulate electromagnetic radiation in the vis...
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.
