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No Authorization For OTC Monograph Reform And User Fees, But Webinar Goes On

FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.

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FDA will not be able to implement its proposed OTC monograph reform and user fee rules on the Oct. 1 start of federal fiscal year 2018 as those changes were contingent on Congress passing enabling legislation.

Legislation to change the monograph process and authorize user fees to pay for FDA’s work has not made it beyond...

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