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US FDA May Play Central Role In Assuring Access To Mifepristone Post Roe v. Wade

 
• By Brenda Sandburg

HHS will take steps to increase access to abortion medication and prevent states from banning it, Secretary Becerra says, but also is questioned about whether the FDA can speed up certification of pharmacies and if the Justice Department would sue states banning access.

abortion pill
The Biden Administration vowed to protect access to the abortion pill. • Source: Shutterstock

The Biden Administration plans to increase access to the abortion pill Mifeprex (mifepristone) as a way to lessen the devastating impact of the US Supreme Court’s overturning Roe v. Wade. While it has presented no specifics on how it will do so, the US Food and Drug Administration could have a significant role in the endeavor.

Health and Human Services Secretary Xavier Becerra announced at a 28 June press briefing that ensuring access to medication abortion...

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Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By Lisa Takagi

While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.