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

USA - March 6 2013
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and…

Co-authors: Elinor L. Hart, Michael A. Swit.

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

USA - February 25 2013
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited rules (the "Rules") detailing manufacturers'…

Co-authors: Elinor L. Hart.

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

USA - 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…

Co-authors: Rachael G. Pontikes.

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

USA - 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.

Co-authors: Elinor L. Hart, Michael A. Swit.

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

USA - 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

Co-authors: Carolyn A. Alenci.

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