Human Drugs
Dare Bio Advancing Bacterial Vaginosis Therapy
FDA grants Dare Bioscience a qualified infectious disease product designation for its bacterial vaginosis therapy.
Medical Devices
Fresenius Kabi Recalls Infusion Pumps
Fresenius Kabi recalls its Volumat MC Agilia Infusion Pumps and Vigilant Agilia Drug Library due to alarm and multiple software errors.
Human Drugs
Dem Senators Want AveXis Punished Over Data Manipulation
A group of U.S. Senate Democrats urge FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting manipulated data in its BLA for re...
Medical Devices
Shimadzu Medicals Fluorospeed X1 Cleared
FDA clears a Shimadzu Medical Systems 510(k) for the Fluorospeed X1 patient side conventional radiographic/fluoroscopic table system.
Human Drugs
Comments Extended on Animal Drug Studies Meeting
Federal Register notice: FDA extends the comment period on a 7/9 notice about a public meeting alternative clinical trial approaches for new animal dr...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/9/2019.
FDA General
Since Our last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 8/9/2019.
Medical Devices
Endologix Study for Aortic Aneurysms Device
FDA gives Endologix authorization to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealin...
Human Drugs
Suit Seeks Info on Any Sharpless Drug Conflict
Watchdog group Restore Public Trust files suit to get FOI documents on whether FDA acting commissioner Ned Sharpless is asserting any influence at the...
