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Court Ruling Compels Emergency Contraceptives Over The Counter

 
• By Dan Schiff

Under a federal judge’s order, FDA must reverse its denial of the Center for Reproductive Rights’ 12-year-old citizen petition and allow universal OTC access to Plan B One-Step and equivalent levonorgestrel-based emergency contraceptives within 30 days.

Plan B One-Step and equivalent emergency contraception products must be approved for universal OTC access by May 4, under a federal judge’s ruling against FDA and the Department of Health and Human Services.

Twelve years after being filed and more than a year after being denied, the Center for Reproductive Rights’ citizen petition...

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A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

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• By Sue Sutter

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