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AN ANALYSIS OF THE LIKELY IMPACT OF THE PROPOSED ASC CHANGES

AN ANALYSIS OF THE LIKELY IMPACT OF THE PROPOSED ASC CHANGES William A. Sarraille, Esquire 1 Elizabeth H. Saindon, Esquire 2 Allison Shuren, Esquire 3 Arent Fox Kintner Plotkin & Kahn, P.L.L.C.

9th Annual LifeScience Alley Conference & Expo, Dec. 8, 2010 ...

As FDA is in the process of internally reviewing various aspects of medical device clearance programs, namely the 510(k) clearance process, CDRH's recently appointed director Dr. Jef-frey Shuren and key members of his senior staff are making stops in Minneapolis, Boston, and Los Angeles to meet ...

Uchideshi Week 07. - 13. August 2011

Uchideshi Week 07. - 13. August 2011 Aiki Shuren Dojo Korntal The Aiki Shuren Dojo Korntal invites Aikidoka from all styles to train intensively Dento Iwama Ryu Aikido as uchideshi for one week.

OIG Rejects Gainsharing Arrangements Between Hospitals and ...

OIG Rejects Gainsharing Arrangements Between Hospitals and Physicians Allison Weber Shuren, Esquire 1 and Bill Sarraille, Esquire 2 Arent Fox Kintner Plotkin & Kahn, P.L.L.C.

Boost Your Bottom Line by Challenging Medical Necessity Denials

articles to well-known, respected, peer-reviewed journals, she advises. ■ Finally, list information from the manufacturer of the technology or pharmaceutical company if it seems extremely helpful—but given their obvious bias, these materials aren't as persuasive, Shuren says.

www.mastercontrol.com

Based on the recommendations in both volumes, Dr. Shuren, in a letter dated August 2010, 2 and in audio conferences, 2,3 listed three areas that form the core of the recommendations: A) Fostering Medical Device Innovation, B) Enhancing Regulatory Predictability, and C) Improving Patient Safety.

For the Southern California Life Science Community

Shuren reiterated that the agency does not concur with this suggestion, and encouraged input from the industry through the comment process. Other speakers talked about issues that included effectively managing relationships with the FDA and critical study design and execution.

OIG work plan for 2007 highlights compliance risks

For more information: Alan E. Reider, JD, and Allison Weber Shuren, MSN, JD , can be reached at Arent Fox PLLC, 1050 Connecticut Ave. NW, Washington, DC 20036; 202-857-6462; fax: 202-857-6395; e-mail: reider.alan@arentfox.com; shuren.allison@ arentfox.com.

Client Alert

These are some of our thoughts on where industry and FDA are at after the dialogue: ∞ We think Dr. Shuren heard from the Minneapolis Town Hall crowd that there are real concerns with his organization from the standpoint of predictability, transparency and reasonableness . ∞ He seems to have a handle ...

Rockland Orthopedics & Sports Medicine, P.C.

Rockland Orthopedics & Sports Medicine, P.C. Cheryl J. Rubin, M.D. ∗ William L. Davis, Jr., M.D. ∗ Michael I. Resnick, M.D. ∗+ Michael D. Robinson, M.D. † Kenneth S. Austin, M.D. ∗ Warren K. Slaten, M.D. † Neal H. Shuren, M.D. ∗ Steven A. Renzoni, M. D. ∗ Yining Zheng, M.D ...