Federal Register notice: FDA seeks public comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to requ...
Federal Register notice: FDA announces a 7/17 public workshop entitled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical In...
CDERs Office of Prescription Drug Promotion issues Vivus an untitled letter over false and misleading claims made on its Web page for weight-loss drug...
Novis PR recalls five lots of PexGen DMX, 16 oz, liquid cough syrup due to incorrect dosage information on its label due to a typographical error.
FDA and precision medicine technology company COTA, Inc. collaborate to establish a real-world evidence study protocol with an initial focus on breast...
FDA kicks off a long-awaited public hearing on cannabis-derived products by placing emphasis on ensuring marketers do not make drug-like claims, while...
CBERs Office of Compliance and Biologics Quality sends an untitled letter to R3 Stem Cell because its Web site promotes its regenerative stem cell the...
FDA approves a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjun...