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Research-related payments and the Physician Payment Sunshine Act: how reporting works and what applicable manufacturers should consider

Duane Morris LLP
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USA
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March 6 2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and

CMS publishes Physician Payment Sunshine rules; manufacturers and group purchasing organizations are required to submit detailed annual reports

Duane Morris LLP
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USA
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February 25 2013

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited rules (the "Rules") detailing manufacturers'

U.S. government's use of the Park Doctrine to police pharmacies

Duane Morris LLP
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USA
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January 7 2013

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act

FDA suspends Sunland, Inc.; major peanut butter producer hit with first food facility suspension under the Food Safety Modernization Act of 2011

Duane Morris LLP
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USA
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November 30 2012

On November 26, 2012, the U.S. Food and Drug Administration (FDA) announced the suspension of the registration of Sunland, Inc., a producer of nuts, and nut and seed spreads, pursuant to the FDA's authority under Section 102 of the Food Safety Modernization Act of 2011

FDA issues guidance for industry on generic drug user fee amendments of 2012: Q&A

Duane Morris LLP
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USA
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August 29 2012

A failure to pay a required fee may result in a refusal to receive an Abbreviated New Drug Application (ANDA) or any supplement to an ANDA, or in a drug being deemed misbranded

FDA's animal generic drug user fee rates and payment procedures for fiscal year 2013

Duane Morris LLP
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USA
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August 8 2012

The U.S. Food and Drug Administration recently published its Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

D.C. Circuit affirms HHS power to disqualify corporate officials convicted of misdemeanors under the Responsible Corporate Official (RCO) doctrine

Duane Morris LLP
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USA
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August 8 2012

On July 27, 2012, the U.S. Court of Appeals for the D.C. Circuit issued the long-anticipated decision in Friedman v. Sebelius

OIG for HHS publishes solicitation of information and recommendations for revising its Provider Self-Disclosure protocol

Duane Morris LLP
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USA
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June 22 2012

On June 18, 2012, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) published a solicitation for information and recommendations to be used in revising its Provider Self-Disclosure protocol

You can be indicted for deleting text messages

Duane Morris LLP
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USA
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June 1 2012

The United States Department of Justice recently charged Kurt Mix, a former engineer for BP with two counts of obstruction of justice

FDA issues draft guidance on Affordable Care Act Prescription Drug Sample Transparency program: reporting deadline informally extended to October 1, 2012

Duane Morris LLP
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USA
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April 4 2012

On April 3, 2012, the U.S. Food and Drug Administration (FDA) published notice of a Draft Guidance detailing its current compliance policy for the Patient Protection and Affordable Care Act's (ACA) Prescription Drug Sample Transparency program (the "Program"

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