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Buprenorphine Waiver Sheds Little Light On FDA Decision-Making Process

 
• By Sue Sutter

But the agency appeared willing to consider a waiver because the innovator and generic sponsors could not reach agreement on a shared REMS.

FDA’s decision to allow separate Risk Evaluation and Mitigation Strategies for branded buprenorphine transmucosal products and their generic equivalents has shed little light on how it will apply the statutory criteria for waiving the single shared system requirement.

Nevertheless, the agency’s action suggests it will consider a waiver when the innovator and generic sponsors are unable to agree...

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The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

More from North America

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• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

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• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

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• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.