Combination Product Regulation Will Come Under Scrutiny At May 1 Meeting
This article was originally published in The Gray Sheet
Executive Summary
AdvaMed members will have an opportunity to voice concerns over combination product regulation at a May 1 meeting with FDA Combination Products Program Director Mark Kramer
You may also be interested in...
Industry, Rep. Buyer Urge Appropriators To Meet User Fee Funding Goals
Congress may reexamine the amount of funds allocated to the device user fee program in the omnibus FY 2003 spending bill, following the Feb. 3 release of President Bush's FY 2004 budget request, which designates only $1 mil. for premarket review activities at CDRH
Industry, Rep. Buyer Urge Appropriators To Meet User Fee Funding Goals
Congress may reexamine the amount of funds allocated to the device user fee program in the omnibus FY 2003 spending bill, following the Feb. 3 release of President Bush's FY 2004 budget request, which designates only $1 mil. for premarket review activities at CDRH
Potential Jurisdictional Change Draws Protest From Wound Product Firms
Wound healing products for which a primary mode of action cannot be elucidated should remain under the jurisdiction of FDA's device center, according to Apligraf manufacturer Organogenesis