CDRH's Burlington on drug model
This article was originally published in The Gray Sheet
Executive Summary
FDA Center for Devices and Radiological Health Director Bruce Burlington pledges at "all hands" staff meeting March 3 that he is "not going to transfer the so-called 'drug model' from" the Center for Drug Evaluation and Research to the device center. Burlington added that he "is not going to be satisfied with halfway measures when it comes to scientific rigor in the device review process." Burlington was a CDER topsider before moving to CDRH Feb. 22 ("The Gray Sheet" Feb. 8, p. 1).
You may also be interested in...
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.
Xaira Launches With $1bn-Plus And End-To-End AI Strategy
ARCH and Foresite incubated the company and recruited Genentech R&D veteran Marc Tessier-Lavigne to keep data generation, machine learning research and drug development under one roof.
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.