FDA posts a guidance on Bacillus Calmette-Gurin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.
Federal Register notice: FDA submits for OMB approval an information collection extension request for Content and Format of Labeling for Human Prescri...
Federal Register notice: CDER announces a continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program.
FDA Review posts the Federal Register notices for the week ending 2/9/2018.
A Washington Legal Foundation brief urges an appeals court to reject a novel theory of liability that would hold pharmaceutical manufacturers liable f...
CDER launches a new system for requesting meetings with Center officials on drug development and drug safety matters.
Federal Register notice: FDA submits for OMB approval an information collection extension for Dispute Resolution Procedures for Science-Based Decision...
FDA extends by three months the user fee review of Salix Pharmaceuticals NDA for Plenvu (NER1006) to review additional data that were recently provide...