Can Courts And States Override FDA’s Drug Regulatory Authority?

Dueling suits seek to force US FDA to withdraw approval of mifepristone or prevent it from doing so while legislation introduced in Idaho would outlaw the use of mRNA technology. Lawyers say these are worrisome challenges to the agency's scientific judgement.

Abortion restriction
Legal battles to prevent use of medication abortion mifepristone challenge FDA's approval authority • Source: Shutterstock

When the Supreme Court overturned Roe v. Wade a key question was what the US Food and Drug Administration might do to ensure access to the medication abortion drug mifepristone. But the decision has had far greater repercussions, as organizations and states are now threatening the agency’s ability to approve and regulate drugs.

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Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 

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Testosterone CV Safety, From Signal To Label

 

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EU Project Aims To Boost Drug Testing Reliability By Replacing Monkeys With Pigs

 
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A new EU public-private initiative is developing tools to help clarify when mini- and micropig models can be used as viable alternatives to non-human primates in non-clinical drug safety testing.

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EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

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European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

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