User Fee Proposals Elicit Cautious Response From Device Center Director
This article was originally published in The Gray Sheet
Executive Summary
CDRH would not welcome a user fee proposal that benefited one premarket review path while taking funds away from others, device center Director David Feigal, MD, asserted April 17
You may also be interested in...
Device Center Modular PMA Submissions Down In FY 2001
FDA received fewer PMA shells and modules in FY 2001 than in previous years, while the proportion of PMA modules found deficient compared to those found acceptable increased
FDA Aims For Greater Efficiency Under Modular PMA Revamp
FDA wants to limit the number of premarket components sponsors can submit under its modular PMA program in order to ensure efficient use of its device review resources.
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.