Three stakeholders raise some concerns about an FDA proposal for an expanded 510(k) pathway.
FDA commissioner Scott Gottlieb creates a Drug Shortages Task Force to find new solutions to the problem of drug shortages.
FDA says scammers are sending fake Warning Letters to consumers who bought drugs online or over the telephone.
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FDA posts a draft guidance entitled Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs.
Federal Register notice: FDA makes available a draft guidance entitled Human Gene Therapy for Hemophilia; Draft Guidance for Industry.
Federal Register notice: FDA makes available a draft document entitled Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.