FDA Office Of Device Evaluation: People, Products On The Move
This article was originally published in The Gray Sheet
Executive Summary
With a recent reorganization and user-fee-program ramp-up, there is a lot of hiring and promotion activity at ODE, and also some occasional head scratching about a device’s appropriate review-branch home, according to Christy Foreman, who directs the office that serves as a U.S.-market gatekeeper for many medical devices.
You may also be interested in...
CDRH’s Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals
In an interview with “The Gray Sheet,” CDRH’s Acting Clinical Trials Director Owen Faris discusses the device center’s new pre-market clinical trials program aimed at speeding up approval times for investigational device exemptions and increasing the number of IDE trials in the U.S.
ODE Reorganization Reduces Reviewer-To-Manager Ratio
A restructuring in the Office of Device Evaluation, incorporating dozens of new hires, is intended to reduce the number of reviewers reporting to each manager. It took effect last week.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.