Medical devicemakers double down on FDA

Medical device manufacturers are doubling down on the FDA, agreeing to pay $595 million in fees over 5 years in exchange for promises of more and faster approvals and better communication from the agency. That is about twice what was paid under the program that expires Sept. 30. The FDA said it will hire about 200 people to speed up the process, and an independent consultant to recommend process improvements. Release | Story

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.