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PDUFA Hearing Will Address NDA Approval Slowdown Claims

This article was originally published in The Tan Sheet

Executive Summary

Drug approval times will be one topic of interest at the House Energy & Commerce/Health Subcommittee's May 3 hearing kicking off the user fee reauthorization process, Commerce Committee Majority Counsel Brent Del Monte told the Food & Drug Law Institute conference in Washington, D.C. April 18.

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Office of Management & Budget clears FTC request to conduct study on Hatch/Waxman's effects on competition between branded and generic drug manufacturers; OMB approval was not deemed clear-cut, since former Eli Lilly exec Mitch Daniels heads the office. FTC will issue special orders to 30 innovator companies and 70 generics firms questioning impact of Hatch/Waxman's 180-day marketing exclusivity and 30-month stay provisions on innovation; firms must reply within 60 days. Study was first proposed last fall (1"The Tan Sheet" Oct. 16, 2000, p. 13)

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