Vertax Biomedical says FDA improperly tainted an advisory committee meeting that led to agency approval of a BioMrieux 510(k).
A CDRH Webinar discusses ways to improve required annual reports submitted by manufacturers with a custom device exemption.
FDA accepts for review a TherapeuticsMD NDA for TX-001HR, an investigational bio-identical hormone therapy combination of estradiol and progesterone i...
FDA gives IDE approval to InVivo Therapeutics Holdings for a second pivotal clinical study involving the companys Neuro-Spinal Scaffold in patients wi...
Federal Register notice: FDA classifies the extracorporeal shock wave device for treating chronic wounds into Class 2 (special controls).
FDA commissioner Scott Gottlieb says he wants more agency investigators at international mail facilities to help intercept illegal drug shipments, par...
Federal Register notice: FDA seeks comments on an information collection for Reclassification Petitions for Medical Devices 21 CFR Section 860.123 (O...
In a precedent-breaking speech, FDA commissioner Scott Gottlieb tells health insurers they need to change payment practices to help the biosimilars ma...