Supreme Court Could Curtail Mifepristone Access, Lay Out ‘Road Map’ To Challenge FDA Approvals

Court decision on whether an anti-abortion group has standing to challenge FDA actions could dispose of case or open door to similar suits. Ruling will determine if pre-2016 REMS restrictions are reinstated.

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US Supreme Court to decide whether FDA should not have eased restrictions on access to mifepristone • Source: Brenda Sandburg

The US Supreme Court’s ruling in the battle over access to the abortion pill mifepristone could determine whether the tighter pre-2016 restrictions on its use will go back into effect. But more broadly, the case could impact the US Food and Drug Administration’s scientific decisions about other drugs.

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All US FDA Product Centers May Merge Under Planned Agency Reorganization

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

Pink Sheet Podcast: Understanding The US FDA Reduction-In-Force And Its Long-Term Impact

Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.

‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

 

Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.

US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People

 

The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.

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Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues

 
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff

 

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.