The U.S. House of Representatives passes S. 204, the Senate version of the Right to Try Act that was passed by that chamber 8/2017.
FDA commissioner Scott Gottlieb tells the Alliance for Regenerative Medicine that the agency will soon release additional guidance on gene therapy man...
PhRMA asks FDA to clarify several elements of its model-informed drug development pilot program proposal.
MBI Distributing recalls all lots of its homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silv...
Federal Register notice: FDA makes available a draft revised guidance for industry entitled Documenting Electronic Data Files and Statistical Analysis...
FDA makes available a guidance on Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.
FDA posts a guidance entitled Bioanalytical Method Validation that discusses validating bioanalytical methods used in human clinical pharmacology, bi...
FDA clears an Inari Medical 510(k) for the FlowTriever System for treating pulmonary embolism.