[ Price : $8.95]
FDA clears a BioHelix 510(k) for the IsoAmp HSV Assay, which is intended for use in detecting Herpes Simplex Virus (HSV1 & HSV2).[ Price : $8.95]
A journal article by CDER deputy director for clinical science Robert Temple discusses the challenges of obtaining reliable compar...[ Price : $8.95]
Federal Register Proposed rule: FDA proposes to reclassify the external pacemaker pulse generator preamendments Class 3 device int...[ Price : $8.95]
FDA extends a continuing clinical hold on Insmed's Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous my...[ Price : $8.95]
Par Pharmaceutical files a declaratory judgment complaint and a motion for preliminary injunction against FDA over off-label restr...[ Price : $8.95]
FDA's Circulatory System Devices Panel recommends approval of Cook Medical's Zilver PTX Drug-Eluting Stent for treating peripheral...[ Price : $8.95]
Device industry negotiators dismiss FDA's recent user fee proposal that would have allocated funding for device reviewer retention...[ Price : $8.95]
An FDA safety alert seeks to reduce surgical fires in operating rooms.