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Human Drugs

Corporate Whistleblower Center Wants Drug Manufacturing Reports

The Corporate Whistleblower Center solicits reports of unsanitary drug manufacturing conditions from drug company employees.

Medical Devices

Medical Technology Regulation Hearing

The House Energy and Commerce Committee Subcommittee on Health schedules a 5/2 hearing on improving regulation of medical technologies.

FDA General

Senate HELP Committee Backs Gottlieb as Next FDA Head

The Senate Health, Education, Labor & Pensions Committee votes 14 to 9 to report out and send the nomination of Scott Gottlieb as the next FDA commiss...

Human Drugs

FDA OKs Label Changes to Anesthesia/Sedation Drugs

FDA approves label changes on the use of general anesthetic and sedation medicines in children younger than three years.

Human Drugs

Court Misses Drug Preemption Call: Attorney

Attorney Michelle Yeary says a Louisiana federal court erred in focusing on Xarelto before FDA approval rather than the marketed drug in ruling that a...

Federal Register

Workshop on Sentinel Queries

Federal Register notice: FDA announces a 7/10 public workshop entitled Sentinel Training at FDA.

Human Drugs

FDA Clears Reapplix 3C Patch System

FDA clears a Reapplix 510(k) for its 3C Patch System including the 3C Patch Centrifuge.

Federal Register

Marathon Granted Priority Review Voucher

Federal Register notice: FDA issues a priority review voucher to Marathon Pharmaceuticals for its recently approved Emflaza (deflazacort) tablets and ...

Human Drugs

CDER Tracking Drug Product Nanotechnology Use

Six CDER staffers say data tracking the use of nanotechnology in drug products shows an increase in such submissions over the last two decades.

Federal Register

Comments Sought on Ampicillin Pediatric Data Report

Federal Register notice: FDA seeks comments on a report evaluating pediatric studies of ampicillin.