Federal Register notice: FDA has submitted for OMB approval an information collection extension related to its regulation on Prominent and Conspicuous...
Federal Register notice: FDA submits for OMB approval an information collection extension for its Guidance for Industry on Postmarketing Adverse Event...
FDA issues an order that will restrict the use of Bayers controversial Essure birth control device to ensure that all women considering the device are...
FDA clears a Fischer Medical 510(k) for the Bloom2 stimulator as a component of electrophysiology procedures to diagnose and treat cardiac rhythm diso...
FDA approves a Pacira Pharmaceuticals NDA for Exparel (bupivacaine liposome injectable suspension) for expanded use as an interscalene brachial plexus...
FDA Review posts the Federal Register notices for the week ending 4/6/2018.
Federal Register notice: FDA announces a 4/23 Science Board Advisory Committee to hear a report from CBER and the committees Research Program Review S...
FDA posts a draft guidance entitled: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.