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Food and Drug Administration (FDA) › Group Purchasing Organizations

Mintz

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

Mintz on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

K&L Gates LLP on

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

McDermott Will & Emery

HRSA Finalizes 340B Program Orphan Drug Exclusion Rules

McDermott Will & Emery on

On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more

Wilson Sonsini Goodrich & Rosati

CMS Issues Final Rule for Implementing Sunshine Act

Wilson Sonsini Goodrich & Rosati on

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

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