FDA clears a Companion Medical 510(k) for an Android version of its InPen app, clearing the way for release of the first smart pen system for Android ...
FDA posts a draft guide from the International Council for Harmonization on cadmium hazards, entitled Elemental Impurities Q3D(R1).
FDA posts a draft guidance entitled Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs.
Federal Register notice: FDA makes available a draft guidance entitled Human Gene Therapy for Hemophilia; Draft Guidance for Industry.
Federal Register notice: FDA makes available a draft document entitled Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.
Federal Register notice: FDA makes available a draft guidance entitled Chemistry, Manufacturing, and Control Information for Human Gene Therapy Invest...
FDA approves Abbotts next-generation MitraClip heart valve repair device used to mend a leaky mitral valve without open-heart surgery.
FDA grants Acceleron Pharma an orphan drug designation for ACE-083, the companys locally acting myostatin+ muscle agent, for treating patients with fa...