Regulatory Affairs Professionals Society

This Week at FDA: Makary’s initiatives stay at FDA, CDRH celebrates 50 years of medtech regulations, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week ...
RAPS

This Week at FDA: CDRH annual report, partial shutdown update, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...
BioWorld

CDRH will emphasize risk management in CY 2026

The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as ...
MD&M East

User Fees Drive Most of the CDRH Increase in FDA’s Budget Request

FDA has released its budget request for fiscal year 2027, which would provide the agency’s Center for Devices and Radiological Health (CDRH) with an increase of more than $91 million over FY 2026.