FDA's New Cross-Cutting Oncology Center Gets Pazdur As Lead
This article was originally published in The Gray Sheet
Executive Summary
FDA's oncology drug guru Richard Pazdur will be heading a new cancer regulatory center aimed at bringing device, drug and biologics regulators together to support new innovations.
You may also be interested in...
Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests
Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.
FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure
Friends of Cancer Research proposes realignment of FDA to be organized more around disease areas and less around the distinctions between drugs, devices and biologics. The idea has generated some support from former commissioners and current officials, while others warn of unintended consequences.
Massive Family Dollar Rat Infestation Leads To Multi-State Recall
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.