Third-party inspections
This article was originally published in The Gray Sheet
Executive Summary
Sen. Edward Kennedy (D-Mass.) will monitor the progress of the U.S./EU mutual recognition agreement (MRA) program before committing to any proposal authorizing third-party inspections of medical device manufacturers, HELP Committee staff suggests. Third-party inspection and review provisions within the Greenwood/Eshoo device reform measure (HR 3580) were chief obstacles to device user fee passage as part of the PDUFA reauthorization package currently awaiting the President's signature (1"The Gray Sheet" May 27, 2002, p. 3). Although industry proponents, including AdvaMed, still hope to fasten user fees to Greenwood/Eshoo, HELP staffers indicate Kennedy remains opposed to third-party reforms without evidence of their benefit. Among issues to be resolved are whether third-party inspections can be conducted while avoiding conflicts of interest. The General Accounting Office has indicated that data are insufficient for analysis of third-party and reuse issues requested by Kennedy earlier this year...
You may also be interested in...
Kennedy To Industry: User Fees Still In Play If Third Party Sits This One Out
Industry supporters of medical device user fees are assuming a formidable challenge by linking the legislative proposal with the "Medical Device Amendments of 2001" (HR 3580), introduced by Reps. Jim Greenwood (R-Penn.) and Anna Eshoo (D-Calif.)
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.