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.

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.

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.