Regulatory News In Brief
This article was originally published in The Tan Sheet
Executive Summary
Proposals to change supplement regs tabled in Senate; Senate wants firm sunscreen rule compliance date; 2012 sees rise in tainted sexual enhancement supplements.
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In Brief
FDA softens disclaimer for green tea QHC; Formulife/Purus covers spectrum of violations; NAD refers Schick case to FTC; Genomma drops Prestige Brands board bid.
Conflict Of Interest Rules Removed In Draft Of House User Fee Bill
Reforms would end waiver caps for conflicts of interest, but whether they will solve the problems patient groups and others have with the advisory committee selection process is unclear. In a discussion draft, FDA could issue as many waivers of financial conflicts as it chose.
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.