Morgan Lewis

Life Sciences

Publications of Interest

104 Publications Found
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May/June 2008 Computer and Software Devices: FDA Seeks Framework for Regulation, FDLI's Update

Outside Publications | Article
Michele Buenafe, M. Elizabeth Bierman

05/08/08 Update on FDA Regulatory/Legislative Issues Impacting Drugs, Biologicals and Medical Devices, presented at the American Health Lawyers Association Life Sciences Law Institute, Bethesda, MD

Presentation | Speech
Phoebe Mounts

04/25/08 Regulatory Process—Navigating the FDA: Moving from Product Concept to Product Clearance/Approval, presented at Morgan Lewis and Pittsburgh Life Sciences' Spring Training Briefing Series, Pittsburgh

Presentation | Speech
M. Elizabeth Bierman

2008 Emerging Life Sciences Companies Deskbook 2008 (second edition)

Book | Morgan Lewis Deskbook
Emerging Growth & Life Sciences Groups

To request a copy, please email deskbook@morganlewis.com with your contact information and with "life sciences" in the subject line.

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04/17/08 Changing Landscape of the Regulatory Pathway for Follow-on Biologics, presented at BayBio2008: Doing Well by Doing Right, San Francisco

Presentation | Speech
Phoebe Mounts

04/14/08 Dividing the Intellectual Property Pie in the Life Sciences Industry, New Jersey Law Journal

Outside Publications | Article
David Glazer, Alan Leeds

April 2008 An Overview of Pharmaceutical and Medical Device Regulation in Japan, Asian-Counsel

Outside Publications | Article
Benjamin Lang

03/28/08 Effective Patent Strategies—Somewhere Between Prosecution and Litigation: An Introduction to Intellectual Property Diligence, presented at Morgan Lewis and Pittsburgh Life Sciences' Spring Training Briefing Series, Pittsburgh

Presentation | Speech
Christopher Halliday

03/27/08 Solving the Challenges of Regulatory Compliance Through Technology, presented at the 51st Annual Food and Drug Law Institute/FDA Conference, Washington, D.C.

Presentation | Speech
Stephen Mahinka

03/13/08 Critical Regulatory Concerns that Must be Addressed in a Life Sciences M&A, presented at the American Conference Institute, New York

Presentation | Speech
Stephen Mahinka

03/12/08 Getting to the Heart of the Business Reasons Behind the Deal and Finding the Right Partner, presented at ACI's Life Sciences Mergers and Acquisitions Conference, New York

Presentation | Speech
Randall Sunberg

02/29/08 Work Smarter. Stay Informed. Employment Law and Public Policy Affecting HR Practice, presented at the Southern California Biomedical Council Human Resources Conference, Los Angeles

Presentation | Speech
Anne Brafford, A. James Vázquez-Azpiri

02/22/08 U.S. Supreme Court Ruling in Riegel v. Medtronic Confirms Preemption for Medical Devices with FDA Premarket Approval

LawFlash/Client Alert | Life Sciences LawFlash
Life Sciences

On February 20, 2008, the U.S. Supreme Court ruled that the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA) preempt most state tort claims that challenge the safety or... more

02/20/08 Overview of Final 403(b) Regulations - What You Need to Know and Do Before the End of 2008, presented at the 9th Annual Emerging Issues in Healthcare Law Conference, San Francisco

Presentation | Speech
James Wynn, Gregory Needles

02/19/08 Negotiating and Living with Consent Decrees, presented at the 6th Annual Food and Drug Law Institute Enforcement and Litigation Conference, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

01/29/08 State Perspectives on Existing and Future Regulations Surrounding Sales and Marketing, presented at the 5th Annual Pharmaceutical Marketing Compliance Congress, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

2008 The Centrality of Regulatory Due Diligence in Life Sciences M&A (Chapter 2), Life Sciences Mergers and Acquisitions (Aspatore Books)

Outside Publications | Chapter
Stephen Mahinka

2007/08 Risk Management for Drugs and Biologics in the U.S., PLC Cross-border Life Sciences Handbook 2007/08

Outside Publications | Chapter
Stephen Mahinka, Kathleen Sanzo

12/06/07 Assessing and Reducing Risks Associated with Medical Information/Product Information Communications, presented at ACI's 6th Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs Conference, Philadelphia

Presentation | Speech
Kathleen Sanzo

11/15/07 Implications of CMS Clinical Research Policy, presented as a webinar for The Center for Business Intelligence

Presentation | Speech
Andrew Ruskin

11/15/07 The Science of Outsourcing, Legal Week

Outside Publications | Article
Richard Barratt, Natalie Kingston

11/08/07 How Are New Safety Concerns Affecting FDA Approvals and CMS Reimbursement of Bio/Pharma Products, presented by The Center for Business Intelligence

Presentation | Speech
Stephen Mahinka

10/08/07 Patent Wars: New Landscape, New Strategies, presented at Biotech 2007: A Joint Symposium of the Biotechnology Council of New Jersey and Pennsylvania Bio, Philadelphia

Presentation | Speech
Louis Beardell, Jr.

10/02/07 Regulatory Trends Affecting Product Approvals and Reimbursement of New Drugs and Biologics, presented at the 8th Annual Philadelphia-Japan Health Sciences Dialogue, Philadelphia

Presentation | Speech
Stephen Mahinka

Autumn 2007 Thinking Outside the Box, European Biopharmaceutical Review

Outside Publications | Article
Richard Barratt, Natalie Kingston

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