Rep. Rosa DeLauro says FDA has told her a mandated new rule on breast density notification should be issued by early 2023.
FDA warns Chinas Beijing Xinggu Lvsan about CGMP violations in its illegal marketing of misbranded unapproved new drugs.
FDA posts a draft guidance entitled Tissue Agnostic Drug Development in Oncology. The document provides recommendations to sponsors on considerations ...
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FDA posts a draft guidance entitled Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical T...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 ...
