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What Makes a Patient a "Patient"? Court Rejects Restrictive 340B Definition | McDermott Will & Emery

On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a. ....

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HRSA Proposes To Overhaul 340B Dispute Process - Food and Drugs Law

On November 29, 2022, the Health Resources and Services Administration ("HRSA") published a notice of proposed rulemaking ("Proposed Rule") to implement an Administrative Dispute Resolution ("ADR"). ....

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HRSA ADR Panel Dismisses NACHC's 340B Complaint Against Two Drug Manufacturers - Healthcare

He 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal. ....

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Polymorphism of a pharmaceutical compound refers to its state of existing in different solid forms that is caused by the fact that the molecules of the compound, though being of the. ....

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A New Year For Drug Pricing And Price Reporting? What's Happening Now And What's New For 2022 - Food, Drugs, Healthcare, Life Sciences

The past two years have featured a flurry of legislative action, agency rulemaking and executive orders targeting the pricing of pharmaceutical and biologic products and related price reporting obligations. ....

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