Federal Register notice: FDA extends the comment period for a draft guidance entitled Process To Request a Review of FDAs Decision Not To Issue Certai...
Federal Register notice: FDA seeks comments on an information collection extension entitled Investigational New Drug Application21 CFR Part 312.
Federal Register notice: FDA has announced the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fi...
Federal Register notice: FDA announces a 10/17 regional public meeting entitled U.S. Food and Drug Administration and Health Canada Joint Public Consu...
Silver Star Brands recalls six products for humans (including four Native Remedies and two Healthful Naturals and two PetAlive products after testing ...
The New Jersey Supreme Court dismisses 532 failure-to-warn cases alleging that Roche failed to provide adequate warnings about the risk of inflammator...
Two stakeholders praise an FDA pilot meeting program for complex innovative drug trial designs.
FDA clears an Allergan 510(k) for its CoolSculpting nonsurgical fat reduction device to treat the submandibular (below the jawline) area.