Human Drugs
FDA Priority Review on La Jolla Hypotension Drug
FDA accepts for priority review a La Jolla Pharmaceutical Co. NDA for the investigational drug LJPC-501 (angiotensin II) for treating hypotension in a...
Medical Devices
FDA Approved Ortho BLA for Blood Grouping Reagents
FDA approves an Ortho Clinical Diagnostics BLA for the Ortho Sera blood grouping reagents designed for extended phenotype testing with the ID-Micro Ty...
Human Drugs
FDA Panel to Review Interstitial Cystitis Drug Development
Federal Register notice: FDA announces a 12/7 Bone, Reproductive and Urologic Drugs Advisory Committee meeting.
FDA General
FDA Warning Letters Drop on Potential Trump Effect
FDA watchers worry that a significant recent drop in Warning Letters issued to medical product makers is a sign of President Donald Trumps anti-regula...
Medical Devices
Cook Medical Corrects Instructions on Endovascular Graft
FDA says Cook Medical has initiated a correction to its instructions for use for the Zenith Alpha Thoracic Endovascular Graft.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/25/2017.
Federal Register
Draft Guide on Drug Supply Trading Partners
Federal Register notice: FDA makes available a draft guidance entitled Identifying Trading Partners Under the Drug Supply Chain Security Act.
Medical Devices
FDA Tells Medizone to Use De Novo Pathway for Disinfection Device
FDA tells Medizone International that it should proceed to market through the de novo classification pathway for its novel AsepticSure disinfection sy...
Human Drugs
FDA Releases More Details on CDER/ORA Inspection Agreement
FDA releases more details on a CDER and ORA concept of operations agreement to integrate facility evaluations and inspections for human drugs.
