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FDA's Proposed Rules to Address Inaccurate Orange Book Use Codes May Shorten Approval Timelines for Select 505(b)(2) and Generic...

Drug Approval and Patent Listing Process - Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more

Judge’s Order to Unwind Hospital’s Acquisition of Physician Group Tests Boundaries of Antitrust Laws and the Affordable Care Act

A federal judge’s recent order to unwind the acquisition of Saltzer Medical Group, an independent physicians group, by St. Luke’s Health System, Ltd., a hospital system with its own staff of physicians, presents challenges...more

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