Federal Register notice: FDA issues an order permanently debarring Gregory Settino from providing services related to an approved or pending drug prod...
FDA posts a draft guidance entitled Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical T...
Medtronic announces that a backup controller with modified software can be used if the primary controller fails to restart its HeartWare Ventricular A...
FDA makes available a final guidance entitled Acute Myeloid Leukemia (AML): Developing Drugs and Biological Products for Treatment.
Federal Register notice: FDA amends its regulations to require that certain data elements be submitted for veterinary devices that are being imported ...
FDA extends by three months its review of an NDA for Biogens tofersen, an investigational new drug intended to treat superoxide dismutase 1 amyotrophi...
FDA revises two compliance programs on inspections effective 10/17 CP 7346.832 Preapproval Inspections and CP 7356.002 Drug GMP surveillance inspecti...
Former FDA commissioners Mark McClellan and Scott Gottlieb say the recent user fee reauthorization was a profound missed opportunity to reform FDA reg...
