Morgan Lewis

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Fast Facts

LMG Life Sciences 2012 – Recommended for FDA – Pharmaceuticals and Healthcare: Pricing and Reimbursement

PLCCross-border Quarterly 2012 Life Sciences Legal Market Review

  • Industry Super League - Ranked 14th among law firms worldwide
  • Regulatory Super League - Ranked 8th 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 2012: Washington, D.C. for healthcare/ pharmaceutical/medical products regulatory – Band 3

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

New Resource

Healthcare Policy and Reform Resource Center

Related Publications

08/25/14 Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process
The draft provides guidance on a streamlined process for submitting requests to the FDA to down-classify certain low-to-moderate-risk devices that have been automatically classified as Class III.
08/06/14 Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged
On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key changes to FDA’s policies that may affect their 510(k) submissions, including new limitations on the use of multiple predicates, the unacceptability of split predicates, an increase in the content and detail required for 510(k) summaries, and FDA’s intent to “verify the accuracy and completeness” of 510(k) summaries.
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Related News

07/24/14 Biosimilars Clarity Coming as FDA Eyes Sandoz Application, Law360
FDA partner Stephen Paul Mahinka is quoted regarding the FDA's landmark decision that should answer how copycat products will be named and deemed interchangeable with their branded counterparts.
05/13/14 FDA Sheds New Light On Biosimilars Approval Pathway
Life sciences partner Stephen Paul Mahinka is quoted.
05/08/14 Morgan Lewis Advises Chelsea Therapeutics on Sale to Lundbeck
H.  Lundbeck A/S and Chelsea Therapeutics International, Ltd. today announced that the companies have entered into a definitive agreement under which Lundbeck will acquire Chelsea.
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Compliance Resources

New Resource: Health Industry Transparency Compliance Resource Center

Health Compliance Brochure

FDA Food Safety Modernization Act

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.