Federal Register notice: FDA seeks comments on a new information collection related to a Draft Guidance for Industry How To Prepare a Pre-Request for...
Attorney Michael Blume says Justice Department briefs in the DeCoster Quality Egg case appeals give valuable insights into how it will prosecute corpo...
FDA approves a Puma Biotechnology NDA for Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer.
FDA commissioner Scott Gottlieb orders a comprehensive review of the agencys hiring practices and procedures in order to speed up processes to bring n...
FDA issues Amgen a Complete Response Letter on its BLA for the Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis.
FDA tells Repros Therapeutics that its clinical development program for Proellex, an oral delivery mechanism for telapristone acetate for treating ute...
FDA revises an internal policy on Communicating Drug Approval Information that demands quicker online posting, from three days to two days, for the ap...
FDA has cleared a CSA Medical 510(k) to expand the use of its truFreeze catheter offerings to include a third spray kit called RapidAV Spray Kit.