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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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• By Derrick Gingery

Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.

German Quaternary Wastewater Treatment Cost Estimates ‘Not Realistic’

 
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New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
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More from Policy & Regulation

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

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Inspection Readiness 101: Prepare To Avoid Common Pitfalls When The FDA Comes Knocking

 
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