PhRMA Defends 30-Month ANDA Stay In McCain/Schumer Position Paper
This article was originally published in The Tan Sheet
Executive Summary
The brand vs. generic industry positioning surrounding proposed Hatch/Waxman process reforms includes conflicting arguments over the potential for standard intellectual property procedures to protect pharmaceutical companies from patent infringement.
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A House subcommittee will examine FDA's legal authority to initiate an Rx-to-OTC switch without the sponsor's consent during a June 13 hearing.
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A House subcommittee will examine FDA's legal authority to initiate an Rx-to-OTC switch without the sponsor's consent during a June 13 hearing.