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‘Storm Of Change’ Could Propel Industry On Making Daily Oral Contraceptive Available OTC In US

 
• By Malcolm Spicer

“It’s going to be industry people like me that have to make a decision that we're going to spend the time, we're going to spend the money to work with FDA for the many years it takes generally speaking to get these things approved,” says Femasys CEO Kathy Lee-Sepsick.

• Source: Shutterstock

The chief executive of a woman’s reproductive health technology developer suggests pharma and medtech firms ask why an oral daily contraceptive isn’t already available OTC in the US, and answer by taking responsibility to make it happen.

“We all could probably agree that women understand how to use their birth control pills, they've had access to them...

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More from Policy & Regulation

NDA User Fees Increasing 8.6% As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

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Senate HELP Committee Adds Sunscreen Regulation Overhaul To OMUFA Reauthorization

 
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