A group of physicians under the Mifeprex REMS Study Group are calling for FDA to withdraw a risk evaluation and mitigation strategy program for the me...
Spectral Medical says it plans to submit in the second quarter the last of four modules for a PMA for Toraymyxin, indicated for treating patients with...
A new National Academies book on the science, ethics, and governance of human genome editing looks at the role FDA plays as one of several bodies invo...
ProPublica takes a lengthy look at academics-for-hire who help drug companies justify high drug prices through Precision Health Economics, a consultin...
Researchers say that medical device company decision makers often over- or under-react to adverse event reports when considering device recalls.
FDA issues Amphastar Pharmaceuticals a complete response letter on an NDA for naloxone hydrochloride 2mg/0.5mL nasal spray, indicated for the emergenc...
FDA accepts an Ocular Therapeutix NDA resubmission for Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use for treating ocular pain occurr...
PhRMA says an International Council on Harmonization revision of an addendum on clinical investigation of medicinal products in pediatric patients is ...