FDA FY 2004 approps
This article was originally published in The Gray Sheet
Executive Summary
AdvaMed June 18 "fly-in" will bring member CEOs to Congress to advocate additional funds for device user fee program. On that day, AdvaMed plans to unveil the Senate Medical Technology Caucus. Regarding user fees, an April 11 letter from Senate HELP Committee Democrats to Senate Appropriations/Ag Subcommittee Chairman Robert Bennett (R-Utah) seeks a $28.5 mil. increase in the FY 2004 FDA budget to sustain the program and help the agency meet performance goals. Bennett is expected to meet with individual device execs in May...
You may also be interested in...
Thompson on user fees
Additional Medical Device User Fee & Modernization Act funds are forthcoming, HHS Secretary Tommy Thompson assures FDA Science Forum attendees April 24 in Washington, D.C. Responding to an audience query about the role of the Office of Management & Budget in device appropriations, Thompson reported that FDA Commissioner Mark McClellan "advanced the budget with the money in, and we advanced it to OMB. I didn't realize that in America we had a 'Super God' until I came to Washington, D.C., and I found out [it] is OMB. Congress is going to respond.... We have to work within the guidelines with OMB, [but] at the end of the day...I am absolutely certain there's going to be some additional money" for devices. Industry is seeking a $28.5 mil. increase in the FY 2004 FDA budget to sustain the user-fee program (1"The Gray Sheet" April 21, 2003, In Brief)...
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Kahn Says
The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.