Morgan Lewis

FDA & Healthcare

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FDA Food Safety Modernization Act

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Related Events

02/29/12-03/02/12 2012 IMS Managed Markets Services/DataNiche Conference Las Vegas, NV
Donna Lee Yesner, speaker
03/22/12-03/24/12 ABA Section of Business Law Spring Meeting 2012 Las Vegas, NV
Arianne Callender, panelist, "New and Evolving Threats from the Responsible Corporate Officers Doctrine"
03/29/12-03/31/12 National Hospice and Palliative Care Organization (NHPCO) 27th Management and Leadership Conference National Harbor, MD
Howard Young, panelist, "The OIG and Hospice in Nursing Facilities: Past, Present and Future"
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Related Publications

02/06/12 CMS Proposes Major Changes to AMP Rule
The Proposed Rule provides provisions that will significantly impact pharmaceutical manufacturers' rebate liability, price reporting calculations, and possibly their operations.
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Related News

09/06/11 Former FDA Regulatory Counsel Returns to Morgan Lewis
Morgan Lewis announces that Alexis Reisin Miller has returned to the firm as a partner in its FDA & Healthcare Practice, resident in Washington, D.C.
07/13/11 Morgan Lewis Team Advises Kinetic Concepts on Company’s $6.3 Billion Acquisition by Apax
Morgan Lewis advised Kinetic Concepts, Inc. (KCI), on a definitive merger agreement under which a consortium comprised of private equity funds will acquire KCI in a $6.3 billion transaction.
05/11/11 Morgan Lewis Further Expands FDA & Healthcare Practice with Government Healthcare Contracts Duo
Morgan Lewis announces that Donna Lee Yesner and Stephen E. Ruscus have joined the firm as partners in its FDA and Healthcare practice, resident in Washington.
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Fast Facts

PLCCross-border Quarterly 2009 Life Sciences Legal Market Review

  • Industry Super League - Ranked 16th among law firms worldwide
  • Regulatory Super League - Ranked 7th among law firms worldwide

PLCCross-border Life Sciences Handbook 2007/2008

  • U.S. - Recognized for commercial/ partnering, competition/ antitrust, corporate, government law enforcement/ investigations, regulatory, regulatory/ medical devices, and patent counseling
  • England - Recognized for regulatory
  • Japan - Recognized for corporate/commercial

Chambers USA 2011: Washington, D.C. for healthcare/ pharmaceutical/medical products regulatory – Band 3

UK Legal 500 2007/2008: London: Pharmaceuticals and Biotechnology

New Resource

New Resource: Health Industry Transparency Compliance Resource Center

Morgan Lewis understands the challenges facing the health industry in this era of increasing governmental regulation and enforcement. The pace of new regulations and statutes affecting regulatory obligations, reimbursement, and coverage creates new opportunities and challenges for manufacturers and suppliers, providers, payors, and patients. Health industry sectors are becoming increasingly interconnected and the laws governing them are closely linked. Providing effective and efficient legal services to the health industry requires integrated legal advice that addresses different regulatory structures and emerging industry developments.

Morgan Lewis has assembled a group of nationally recognized FDA and healthcare attorneys and professionals who take a collaborative and integrated approach to the representation of health industry clients in matters involving FDA, health regulatory, reimbursement, finance, policy, corporate, privacy/security, compliance, and government enforcement matters. On complex matters, our integrated approach gives clients peace of mind that their issues have been examined from every critical angle.