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Senate OTC Monograph Reform Bill Clears HELP For Floor Vote

 
• By Eileen Francis

Senate HELP Committee approves an OTC monograph reform bill with two-year market exclusivity for some products. The bill also establishes a user fee program to pay for FDA's work and replaces public rulemakings currently required for any change with an administrative order process.

Washington DC Capitol dome detail with waving american flag

Legislation to improve and modernize FDA's OTC monograph program has passed another hurdle in Congress with the Senate Health, Education, Labor and Pensions Committee clearing its bill for a floor vote.

The committee on April 24 approved by a vote of 22-1 the “Over-the-Counter Drug Safety, Innovation and Reform” Act,"

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