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

07/22/14 Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter
In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have analyzed some of the more significant guidances that were issued in the second quarter of 2014 (April–June).
07/17/14 FSIS Proposes New Recordkeeping Requirements for Ground Beef Processors/Retailers
The proposal, if adopted, will require new recordkeeping by both processing establishments and retail facilities that grind raw beef products.
06/24/14 FDA to Cease Active Regulation of MDDS and Other Health IT Devices
The draft guidance also enables some health IT manufacturers to avoid the device tax.
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Related News

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.
11/19/13 Pharmacists, Attorneys Question Whether Drug Compounding Bill Would Improve Safety, BNA's Daily Report for Executives
Although the drug industry generally supports the bill passed by the Senate Nov. 18, attorneys and some pharmacists question whether the bill really would improve the safety of compounded drugs.
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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.