Morgan Lewis

FDA/Healthcare Regulation

Publications of Interest

149 Publications Found
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08/25/08 Request for Comments on the Basic Results Data Entry System for ClinicalTrials.gov to Be Submitted by September 3

LawFlash/Client Alert | FDA-Healthcare Regulation LawFlash
FDA-Healthcare Regulation Practice

In preparation for the implementation of the results data entry system mandated by the Federal Food and Drug Administration Amendments Act of 2007 (FDAAA), the National Library of Medicine has modified the Clin... more

08/05/08 Consumer Product Safety Improvement Act of 2008: New Regulatory Landscape for Product Safety

LawFlash/Client Alert | Consumer Product Regulation LawFlash
FDA-Healthcare Regulation Practice

The Consumer Product Safety Improvement Act of 2008 (the Act) stands to expand not only the staffing, funding, authority, and reach of the Consumer Product Safety Commission (CPSC, or the Commission) at the federal leve... more

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

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

02/25/08 FDA Seeking to Actively Regulate Computer/Software Products That Transmit, Store, or Display Medical Device Data

LawFlash/Client Alert | FDA-Healthcare Regulation LawFlash
FDA-Healthcare Regulation

The Food and Drug Administration (FDA) is proposing to actively regulate a new class of computer- and software-based products that electronically collect, transfer, and store data from medical devices such as glucose me... more

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
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

10/24/07 CMS Withdraws Clinical Trial Policy Proposed Modifications and Creates New Questions

LawFlash/Client Alert | FDA-Healthcare Regulation LawFlash
FDA-Healthcare Regulation

On October 17, the Centers for Medicare and Medicaid Services (CMS) announced that it was not moving forward with controversial proposed changes to its clinical trial policy. CMS’s clinical trial policy governs... more

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
Natalie Kingston

09/13/07 Advancing European Medtech: A Regulatory Perspective, presented at the MedTech Investing Europe 2007 Conference, London

Presentation | Speech
Anthony Warnock-Smith

2007 The Self-Regulation of Medicines in the UK, The International Comparative Legal Guide to: Pharmaceutical Advertising 2007

Outside Publications | Article
Anthony Warnock-Smith, Natalie Kingston

July 2007 Medicare Reimbursement in Clinical Trials for “Standard of Care” in Flux

White Paper | Morgan Lewis White Paper
FDA/Healthcare Regulation

It may no longer be possible to take for granted that Medicare will pay for standard of care treatment in the clinical trial setting. "Standard of care" services are generally understood to be those services th... more

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