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Supreme Court’s Stay Of Mifepristone Ruling Gives FDA Respite For Next Round

 
• By Brenda Sandburg

Medication abortion pill can remain on the market under current conditions until appeal on the merits of the preliminary injunction is decided. Justice Alito dissents, noting that FDA could exercise its enforcement discretion to prevent harm to mifepristone manufacturer Danco.

Supreme building closeup
Supreme Court grants stay of district court order suspending approval of medication abortion drug mifepristone • Source: Shutterstock

The outcry from the biopharmaceutical industry and a host of other organizations may have helped sway the U.S. Supreme Court to stay an order by a Texas district court judge suspending the US Food and Drug Administration’s 2000 approval of the medication abortion drug mifepristone.

On Friday night, the court granted applications by the FDA and Danco Laboratories, manufacturer of the brand name drug Mifeprex, to stay the 7 April preliminary injunction order issued by District Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas

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More from US FDA

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
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US FDA Restoring Some Library Resources

 
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US FDA Advisory Committee Misperceptions Abound … At HHS

 
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HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

More from Agency Leadership

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.