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HEALTH SCIENCE FUNDING, LLC v. THE UNITED STATES FOOD & DRUG ADMINISTRATION et al
Case Number:
2:13-cv-03663
Court:
Nature of Suit:
Judge:
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July 23, 2013
FDA Wants Preemptive Lupus Treatment Suit Nixed
The U.S. Food and Drug Administration on Monday pushed back against Health Science Funding LLC's novel bid for a declaration that labeling on its lupus treatment Prastera complies with FDA requirements for medical foods, arguing that a New Jersey federal court can't step into the agency's shoes and apply its regulations.
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June 13, 2013
FDA Sued For Questioning Lupus Product's Label
Health Science Funding LLC sued the U.S. Food and Drug Administration in New Jersey federal court Thursday, seeking a declaration that the label for its Prastera treatment for women with lupus complies with federal law and an order barring the agency from taking enforcement action saying otherwise.