FDA clears an Optovue 510(k) for its Avanti Widefield Optical Coherence Tomography system for non-contact, quantitative measurements of the epithelial...
Federal Register notice: FDA issues a proposed list of alternative or streamlined mechanisms for complying with GMP requirements for combination produ...
Federal Register notice: FDA makes available a guidance entitled Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Si...
Federal Register notice: FDA makes available a guidance for industry entitled Medical Product Communications That Are Consistent With the FDA-Required...
Federal Register notice: FDA makes available a draft guidance entitled Limited Population Pathway for Antibacterial and Antifungal Drugs.
FDA issues scPharmaceuticals a complete response letter on its 505(b)(2) NDA for Furoscix (subcutaneous furosemide) for treating edema or fluid overlo...
FDA approves Genentechs Avastin (bevacizumab) for use in combination with chemotherapy, followed by Avastin as a single agent, for treating women with...
FDA approves a Wright Medical Group PMA for Augment Bone Graft for use in hindfoot and ankle fusion.