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Second Wind For OTC Monograph User Fee Legislation In House Hearing

 
• By Malcolm Spicer

House Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing Sept. 13 will "examine draft legislation to establish" a user fee program to support FDA's work on evaluating proposals for additions or changes to its nonprescription drug monographs.

Chances this year for legislation on reforming FDA's OTC drug monograph program and creating a user fee to support it could be revived as a House subcommittee expects to have a draft bill ready for a hearing on Sept. 13.

The Energy and Commerce Committee's Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing will "examine draft legislation to establish"...

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• By Malcolm Spicer

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Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

 
• By David Ridley

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• By Malcolm Spicer

Attorney Jonathan Emord says federal court’s grant of standing for Alliance for Natural Health USA and Meditrend to challenge FDA’s safety concerns about homeopathic drugs leaves open a door to continue arguing the agency violated multiple regulations by imposing NDA requirements for homeopathics.

Producers Sue Oregon Over ‘Crushing’ EPR Recycling Law, Call It Unconstitutional

 
• By Eileen Francis

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FDA RIF Delays Response On NPA NMN Petition

 
• By Malcolm Spicer

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