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Philip E. Johnson, George Dahlman, Kirby Eng, Rekha Garg, Scott Gottlieb, James M. Hoffman, Peyton Howell, Mohammad Jahanzeb, Shirley Johnson, Emily Mackler, Mark Rubino, Brenda Sarokhan, F. Marc Stewart, Tim Tyler, Julie M. Vose, Sharon Weinstein, Edward C. Li and Jessica DeMartino

Evaluation and Mitigation Strategies (REMS) are the newest tool of the FDA to help manage and ensure safe drug use. The FDA may require manufacturers to develop REMS for both existing drugs and those in development when it determines that special action is

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Jane M. Quigley

, which allows all of this information to be tied back to the rendering physician, hospital, and pharmacy. The amount of health care data has grown exponentially since the enactment of HIPAA. Figure 1 Blinded use of a product with a REMS program

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Edward C. Li

special edition, we presented the NCCN Oncology Risk Evaluation and Mitigation Strategies (REMS) White Paper, which contained recommendations by the NCCN REMS Work Group and the ruminations from the NCCN REMS Oncology Policy Summit held on May 7, 2010. In

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Edward C. Li

It has been roughly 3 years since legislation was signed into law that gave the FDA authority to require drug manufacturers to provide a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs. The FDA Amendments Act of 2007 (FDAAA) was a

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Stacey W. MucCullough, David Blaisdell, Jonathan K. Kish, Pat Farmer, JaLyna Laney, Tom Valuck, Natalie Dickson, Johnetta Blakely, Dianna Shipley, Jesus Berdeja, Gregg Shepard, Bertrand M. Anz III, Carolyn Kelsey, Jack Taylor, Chadi Nabhan, Jeffrey F. Patton and Annette Powers

Mitigation Strategies (REMS) programs. We sought to understand the fundamental challenges facing a multisite community oncology practice undergoing SP centralization to identify potential quality gaps for patients with MM. Methods: Structured, in

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's New With REMS? On May 7, 2010, NCCN convened the NCCN Oncology Summit: Recommendations for REMS Stakeholders. At this meeting, NCCN highlighted some of the challenges with Risk Evaluation and Mitigation Strategies (REMS) in oncology and emphasized

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percentage of physicians now using smartphones in the United States is 72%. The same report predicts that about 81% of physicians will use smartphones by 2012. For additional information, visit NCCN.org /mobile. NCCN Draft REMS White Paper Now

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Edward C. Li

affect hospitals and oncology practices: Risk Evaluation and Mitigation Strategies (REMS). A few years ago, I received a call from my mother—also a pharmacist—who works for a pharmacy that provides services to long-term care facilities. She was requesting

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question to the “Ask Jai” column, e-mail questions to NCCN.com to view a video of Ms. Pausch speaking about her new column. NCCN REMS Resource Webpage Updated To help oncology clinicians stay current with drugs requiring a Risk Evaluation and

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Harold J. Burstein

meet these evolving oncology needs by providing information on critical topics such as how mandated Risk Evaluation and Mitigation Strategies (REMS) will affect practices and to help pharmacists and care managers understand the changing use of oncology