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Search resuls for: "Julia Harte Gabriella Borter Brendan Pierson"


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Of the various potential rulings possible in the case involving the abortion pill mifepristone, either of those outcomes would be unprecedented judicial intervention in the agency's regulatory process. Some of the FDA's options could be politically and legally risky both for the agency and mifepristone suppliers, they said. The FDA said the pill was deemed safe after extensive studies and use, and that the challenge comes much too late. Under FDA statutes and regulations, drug approval withdrawal generally begins with an informal hearing, which can entail extensive document preparation and the convening of an advisory committee. Overseas provider Aid Access, an Austria-based service that ships abortion medication to U.S. patients, said it would continue providing the pill no matter how the FDA responds.
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