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What Will FDA Do In Battle Over Medication Abortion Access?

 
• By Brenda Sandburg

Attorneys discuss host of questions the agency faces in the wake of the Dobbs decision, including whether to take enforcement action against mifepristone REMS violations, whether to change restrictions on its use, and how to deal with challenges to its drug approval authority.

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FDA facing uncertainty as it grapples with post-Dobbs world • Source: Shutterstock

The US Food and Drug Administration is facing growing pressure from both those who want to expand access to medication abortion and those seeking to restrict or ban its use. As a result, the agency must address questions about the scope and enforcement of its Risk Evaluation and Mitigation Strategy (REMS) for mifepristone and how it responds to challenges of product approvals.

Attorneys discussed the impact of the US Supreme Court’s Dobbs decision on the Food, Drug and Cosmetic Act at a...

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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

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• By Cathy Kelly

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Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

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EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
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EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

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Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

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