FDA/Healthcare Regulation Publications of Interest

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08/01/08 Morgan Lewis's Health Care Practice, Law360

Morgan Lewis's Health Care Practice is recognized in a Law360 profile highlighting the firm's work across life sciences, antitrust, outsourcing, and mergers and acquisitions.

06/13/08 Chambers USA 2008 Recognizes Morgan Lewis in 19 National Practice Areas

Morgan Lewis is pleased to announce that the 2008 edition of Chambers USA: America’s Leading Lawyers for Business features Morgan Lewis as a leading national firm in 19 practice areas.

04/21/08 Morgan Lewis Launches Second Edition of Emerging Life Sciences Companies Deskbook

Morgan Lewis is pleased to announce the launch of the second edition of the Emerging Life Sciences Companies Deskbook.

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Fast Facts

^PLCCross-border Quarterly 2008 Life Sciences Legal Market Review

Industry Super League - Ranked 16th among law firms worldwide
Regulatory Super League - Ranked 6th 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 2008: Recommended in Washington, D.C. for healthcare/ pharmaceutical/ medical products regulatory

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

Areas of Experience

Related Practices

Life Sciences

150 Publications Found

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09/22/08 Competitive Acquisition Program for Medicare Part B Prescription Drugs Stalled

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

Beginning January 1, 2009, physicians will no longer be able to participate in the Medicare Part B Competitive Acquisition Program (CAP). The Centers for Medicare and Medicaid Services (CMS) announced on Septem... more

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.

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

07/25/07 Medicare Reimbursement for “Standard of Care” in Flux

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

Medicare has proposed new rules as to when reimbursement is available for standard of care treatment furnished to clinical research subjects. “Standard of care” services are generally understood to be those ser... more

07/18/07 CMS Proposes Changes to Its Policies Governing Off-Label Uses of Anticancer Drugs and Biologicals

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

A recently issued proposed change to Medicare policy could significantly affect Medicare payment for anticancer drugs and biologicals. The Centers for Medicare and Medicaid Services (CMS) has proposed a laundry... more

06/29/07 FDA Regulation of Medical Devices, presented at the D.C. Bar Health Law Section and Litigation Section Off-The-Record Luncheon Program, Washington, D.C.

Presentation | Speech
Phoebe Mounts

06/28/07 Final Rule for Dietary Supplement GMPs

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

On June 25, the FDA issued the long-awaited good manufacturing practice (GMP) requirements for dietary supplements. The final regulation applies to all firms that manufacture, package, label, or hold dietary su... more

06/19/07 Proactive Steps Every Provider Should Take to Avoid Government Scrutiny, presented at ACI's Preparing for Government Healthcare Fraud Enforcement Conference, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

06/18/07 New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

05/17/07 Compliant Models for Medical Device Grants, presented at CBI's Premier West Coast Conference on Bio/Pharmaceutical and Medical Device Grants, San Francisco

Presentation | Speech
Kathleen Sanzo

05/17/07 Regulatory and Corporate Considerations in Life Sciences Industry Investments, presented at a Morgan Lewis Seminar, Palo Alto

Presentation | Speech
Kathleen Sanzo, Denis Segota

04/26/07 Sailing to FDA Product Approval: Innovations in the Clinical Trial Paradigm, presented at Bay Bio 2007, San Francisco

Presentation | Speech
Phoebe Mounts

04/17/07 Managing Customer Communications in a Post-Neurontin World, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.

Presentation | Speech
M. Elizabeth Bierman

04/17/07 The AdvaMed Code of Ethics, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

03/22/07 The Patient's Nose Under the Tent: The Impact on Hospitals of State and Federal Healthcare Transparency Initiatives, presented at the American Health Lawyers Association's Institute on Medicare and Medicaid Payment Issues, Baltimore

Presentation | Speech
Andrew Ruskin

03/21/07 2006: The RAP Practice Group's Year in Review, presented at the American Health Lawyers Association's Institute on Medicare and Medicaid Payment Issues, Baltimore

Presentation | Speech
Andrew Ruskin

03/02/07 Potential Challenges to Pricing of Biotech Products: Medicare/Medicaid and Related Pricing Developments, presented at the 2007 BIO General Counsels' Committee Meeting

Presentation | Speech
Stephen Mahinka, Andrew Ruskin

2007 Keys to Successful Interactions with Governing Bodies, Inside the Minds: Food and Drug Law Settlements and Negotiations

Outside Publications | Article
Kathleen Sanzo

January 2007 The New Congress: Outlook for Health Care Legislation in 2007, presented at the Fulbright & Jaworski Health Law Teleconference, Washington, D.C.

Presentation | Speech
Anne Sullivan

October 2006 Navigating the Road Ahead: E-Discovery and Information Management Workshop, presented at Fulbright & Jaworski, LLP, Washington, D.C.

Presentation | Speech
Anne Sullivan

08/24/06 Risk Management Strategy for the Pharma and Biotech Product Lifecycle: New Regulatory and Legal Focus and Approach, presented at the 2nd Annual FDA Regulatory and Compliance Symposium, Harvard University, Cambridge, MA

Presentation | Speech
Stephen Mahinka

07/18/06 Crossing Paths with the FDA—Regulatory Influence on the Defense of Drug and Device Products, presented at the Defense Research Institute Teleconference

Presentation | Speech
Kathleen Sanzo

May 2006 DRA May Drive New Relationships, Reimbursement Advisor, Vol. 21, No. 10

Outside Publications | Article
Andrew Ruskin

May 2006 E-Health Initiatives and Federal Legislation, presented at the Greater Washington, D.C. Chapter of ARMA's Annual Seminar, Washington, D.C.

Presentation | Speech
Anne Sullivan

May 2006 Medicare Inpatient Prospective Payment System Proposed Rule for 2007, presented at the Fulbright & Jaworski Health Conference, Washington, D.C.

Presentation | Speech
Anne Sullivan

03/18/06 HIPAA Privacy Rule, presented at the Association of Healthcare Journalists 2006 Conference

Presentation | Speech
Jessica Bernanke

03/01/06 Year in Review, presented at the Medicare and Medicaid Institute, American Health Lawyers Association

Presentation | Speech
Andrew Ruskin

February 2006 OIG 2006 Work Plan, Reimbursement Advisor, Vol. 21, No. 7

Outside Publications | Article
Andrew Ruskin

01/01/06 Compliance Issues Relating to Providing Discounts to the Uninsured, presented at the HCCA 2005 South Atlantic Area Compliance Conference

Presentation | Speech
Andrew Ruskin

01/01/06 Graduate Medical Education (GME) Reimbursement Issues, Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, presented at the American Health Lawyers Association

Presentation | Speech
Andrew Ruskin

January 2006 Implementation of the Part D Drug Benefit, Reimbursement Advisor, Vol. 21, No. 6

Outside Publications | Article
Andrew Ruskin

December 2005 Novel CMS Decision on Beneficiary "Upgrades", Reimbursement Advisor, Vol. 21, No. 5

Outside Publications | Article
Andrew Ruskin

November 2005 Definition of "Claim" Under the False Claims Act, Reimbursement Advisor, Vol. 21, No. 4

Outside Publications | Article
Andrew Ruskin

September 2005 "Questionable" Guidance, Journal of Healthcare Financial Management

Outside Publications | Article
Andrew Ruskin

09/01/05 Compliance Issues Relating to Providing Discounts to the Uninsured, presented at the HCCA 2005 Northeast Area Compliance Conference

Presentation | Speech
Andrew Ruskin

June 2005 "CMS" GME Clarifications, Reimbursement Advisor, Vol. 20, No. 11

Outside Publications | Article
Andrew Ruskin

05/24/05 Defining the "Market" and Its Effect on Antitrust Analysis of Pharmaceutical Company Conduct and Transactions presented at the American Conference Institute; In-House Consul Forum on Pharmaceutical Antitrust, in Washington, D.C.

Presentation | Speech
Scott Stempel

05/24/05 Pharmaceutical Industry Mergers: Anticipating Antitrust Issues and Surviving the Investigation, presented at the American Conference Institute In-House Counsel Forum on Pharmaceutical Antitrust, Washington, D.C.

Presentation | Speech
Stephen Mahinka

May 2005 United States Food and Drug Administration, presented at the Fulbright & Jaworski Health Law Teleconference, Washington, D.C.

Presentation | Speech
Anne Sullivan

March 2005 MMA and Beyond: The Regulation, Accreditation, and Payment Practice Group’s Update, presented at the Medicare Medicaid Institute, American Health Lawyers Association

Presentation | Speech
Andrew Ruskin

11/01/04 Price Reporting Compliance: Best Practices in Reporting Medicaid Drug Rebate Program and Part B ASP Data, presented at the Pharmaceutical Compliance Forum’s Fifth Annual Pharmaceutical Regulatory & Compliance Congress

Presentation | Speech
Andrew Ruskin

October 2004 CMS Revises MSP Requirements for Reference Laboratory Services, Reimbursement Advisor, Vol. 20, No. 2

Outside Publications | Article
Andrew Ruskin

10/01/04 The MMA and its Implementation: 10 Opportunities for the Diligent and 10 Pitfalls for the Unwary, presented at the New Jersey Chapter Healthcare Financial Management Association

Presentation | Speech
Andrew Ruskin

09/01/04 Distinguishing the 800-Pound Compliance Gorillas from the Featherweights: An Analysis of the Weight of Various Regulatory Authorities, presented at the Fraud and Compliance Forum, American Health Lawyers Association

Presentation | Speech
Andrew Ruskin

July/August 2004 New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry, FDLI Update, Vol. 36

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

July 2004 Medicare Implications of Hospital Discounts to the Uninsured, Journal of Healthcare Management

Outside Publications | Article
Andrew Ruskin

April 2004 Stark II, Phase II Interim Final Regulations, presented at the Fulbright & Jaworski Health Law Teleconference, Washington, D.C.

Presentation | Speech
Anne Sullivan

March/April 2004 Strategic Implications of FDA’s Proposed Safety Reporting Requirements, On Drugs: Legislation, Litigation, and Policy Proposals

Outside Publications | Article
Michele Buenafe

March 2004 Medicaid Provisions in MMA, Reimbursement Advisor, Vol. 19, No. 8

Outside Publications | Article
Andrew Ruskin

03/01/04 Significant Provisions of the MMA: Part A and Related Provisions, presented at the Medicare and Medicaid Institute, American Health Lawyers Association

Presentation | Speech
Andrew Ruskin

02/03/04 "Off-Label" Communications at Risk: Changes and Challenges to Reimbursement for Prescription Drugs, presented to the Washington Legal Foundation, Washington D.C.

Presentation | Speech
Stephen Mahinka

02/01/04 New Opportunities for Drugs Under Old Medicare: Changes to Inpatient New Technology Pass-Throughs and "Incident to" Coverage, presented at the National Medicare Prescription Drug Congress

Presentation | Speech
Andrew Ruskin

2004 Pregnant Drug Abusers Are Treated Like Criminals Or Not Treated At All: A Third Option Proposed, Journal of Contemporary Health & Policy, Vol. 21, No. 36

Outside Publications | Article
Anne Sullivan

January 2004 Reimbursement for Residents Training Offsite Under Volunteer Physicians, Reimbursement Advisor, Vol. 19, No. 6

Outside Publications | Article
Andrew Ruskin

11/01/03 Outlier Update, presented at the HCCA Mid-Atlantic Conference

Presentation | Speech
Andrew Ruskin

09/01/03 Achieving Best Practices in Teaching Physician Billing and Supervision, presented at the American Health Lawyers Association Fraud and Compliance Forum

Presentation | Speech
Andrew Ruskin

06/23/03 FDA Approval of Generic Biologics: Adverse Effects on Industry Innovation and Valuation, presented at the Biotechnology Industry Organization Annual Conference, Washington, D.C.

Presentation | Speech
Stephen Mahinka

May 2003 CMS’s Proposed Outlier Regulation, Reimbursement Advisor, Vol. 18, No. 10

Outside Publications | Article
Andrew Ruskin

05/01/03 New Technology Adjustment Under the DRG Payment System, presented at The Future of Medicare Policy for Medical Technologies

Presentation | Speech
Andrew Ruskin

04/01/03 Charges – Why Are They Still Relevant, presented at the Medicare Medicaid Institute, American Health Lawyers Association

Presentation | Speech
Andrew Ruskin

02/28/03 FDA Must Clarify Drug Makers' Ability to Publicly Defend Products, Litigation Legal Foundation Legal Update, Vol. 13, No. 7

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

02/01/03 What Every Compliance Officer Should Know About Coding Evaluation and Management Services Furnished by Physicians and Hospitals, presented at the 6th Annual National Congress on Health Care Compliance

Presentation | Speech
Andrew Ruskin

11/04/02 Navigating a Pathway to FDA Approval

Presentation | Speech
Kathleen Sanzo

10/01/02 APC Coding Update, presented at the HCCA Mid-Atlantic Conference

Presentation | Speech
Andrew Ruskin

10/01/02 FDA Approval of Drugs Under Section 505(b)(2): Potential Expansion and Legal Concerns, presented at the Regulatory Affairs Professionals Society Annual Conference, Washington, D.C.

Presentation | Speech
Stephen Mahinka

09/06/02 FTC, Not FDA, Should Regulate Online Food Information, Legal Backgrounder, Vol. 17, No. 38

Outside Publications | Article
Kathleen Sanzo

08/01/02 FDA Challenges to Pharmaceutical Company Control of Product Lifecycle Management, FDLI Update

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

August 2002 Market Exclusivity: New Legal Developments and Pharmaceutical Marketing Implications, Regulatory Affairs Focus

Outside Publications | Article
Kathleen Sanzo

06/01/02 Pharmaceutical/Biotechnology M&A and Corporate Partnering

Presentation | Speech
Randall Sunberg

05/01/02 Compliance in Writing RFP Responses and Sales Agreements to Purchase a Product from a Referral Source, presented at the Region IV of the Healthcare Financial Management Association

Presentation | Speech
Andrew Ruskin

March 2002 Pharmaceutical Pricing: System Changes And Global Effects, Metropolitan Corporate Counsel

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

02/01/02 Significant Recent Developments in APCs, presented at the Colorado Chapter of the Healthcare Financial Management Association

Presentation | Speech
Andrew Ruskin

02/01/02 The Fundamentals of Coding for Non-Coders and Potential Compliance Issues Related to Coding Activities, presented at the 5th Annual National Congress on Health Care Compliance

Presentation | Speech
Andrew Ruskin

02/01/02 The Fundamentals of Coding for Non-Coders and Potential Compliance Issues Related to Coding Activities, presented at the Health Care Compliance Association Annual Compliance Institute

Presentation | Speech
Andrew Ruskin

January 2002 CMS Reverses Policy Regarding 5.8 Percent Reduction in Inpatient Ancillary Services, Reimbursement Advisor, Vol. 17, No. 5

Outside Publications | Article
Andrew Ruskin

January 2002 OIG's Position on "Prebates", Reimbursement Advisor, Vol. 17, No. 5

Outside Publications | Article
Andrew Ruskin

November 2001 Affiliation Agreements for GME Residency Programs, Reimbursement Advisor, Vol. 17, No. 3

Outside Publications | Article
Andrew Ruskin

August 2001 U.S. Pharmaceutical Pricing: System Changes and Global Effects, Life Sciences Industry Report

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

January 2001 It's Worse Than You Think: US Regulatory Changes Require Pharmaceutical Company Attention, International Financial Law Review: Competition & Antitrust (Special IFLR Supplement)

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo, Willard Tom

January 2001 New Proposed Policy Regarding Imposition of Reporting Requirements on Products Sold Outside of the United States

White Paper | Morgan Lewis White Paper
Kathleen Sanzo

On January 3, 2000, the Consumer Product Safety Commission (“CPSC”) released a proposed policy statement announcing its position that the reporting requirements under section 15(b) of the Consumer Product Safety Act (“CPSA”)... more

12/01/00 Regulatory Litigation in the Innovator Pharmaceutical Industry, presented at the FDLI's Conference on Hatch-Waxman: Past, Present and Future, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

November 2000 California Trial Court Finds Ford Acted Fraudulently by Not Reporting Safety Information to Federal Agenices

White Paper | Morgan Lewis White Paper
Kathleen Sanzo, J. Cooney, Jr.

Last month, a California Superior Court judge issued an opinion following a nonjury trial in which he ordered the recall of nearly 1.3 million Ford motor vehicles due to Ford's failure to disclose and correct defects in its ... more

November 2000 Recoupment of Medicare Overpayments from Providers in Bankruptcy, Reimbursement Advisor, Vol. 16, No. 3

Outside Publications | Article
Andrew Ruskin

09/04/00 Expect Big Change in Drug Pricing System, The National Law Journal

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

June 2000 Providing Off-Label Use Information: New Decision Sends Industry One-Half Step Back, Regulatory Affairs Focus

Outside Publications | Article
Kathleen Sanzo

04/07/00 Antitrust Issues in Electricity Mergers and Joint Activities, presented at the Edison Electric Institute Legal Conference, Colorado Springs, CO

Presentation | Speech
Stephen Mahinka

02/01/00 CPSC 15(b) Reporting Requirements: A Practical Guide to Knowing When and What to Report, presented to the American Bar Association, Orlando, FL

Presentation | Speech
Kathleen Sanzo

11/08/99 Marketing Your Product as a Drug or Dietary Supplement: Legal Risks and Benefits: Outline Presentation, The German-American Chamber of Commerce, Inc. and The Association of the German Pharmaceutical Industry Conference on the Regulatory Framework for OTC Drugs and Dietary Supplements, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

06/29/99 Medical Device Update, presented to the Food and Drug Law Institute, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

March 1999 New Rules on the Protection of Regulatory Data in Europe?, Legal Mind

Outside Publications | Article
Anthony Warnock-Smith

1999 Empowering Patients to Act Like Consumers: A Proposal Creating Price and Quality Choice within Health Care, Saint John’s Law Review, Vol. 73

Outside Publications | Article
Andrew Ruskin

12/07/98 Strategies for Obtaining Market Exclusivity for Genetic Discoveries: Patent, FDA, and Contract Mechanisms, Decision Resources, Inc.

Outside Publications | Article
Kathleen Sanzo

December 1998 The EC Centralised Procedure and Multi-Party Collaborations, The Regulatory Affairs Journal, Vol. 9

Outside Publications | Article
Anthony Warnock-Smith

November 1998 The Protection of Regulatory Data in the European Union, Legal Mind (Japan), Vol. 176
Outside Publications | Article
Anthony Warnock-Smith

09/01/98 The Protection of Regulatory Data After BMS/Generics, presented at the 5th Euroforum Annual Conference, London
Presentation | Speech
Anthony Warnock-Smith

05/15/98 Current Legal Issues for Small and Medium Sized Enterprises, presented at the Pharmaceutical Licensing Group Spring Meeting, Grantham, Lincolnshire, U.K.
Presentation | Speech
Anthony Warnock-Smith

January 1998 FDA Takes Important Step Toward Liberalizing Its Direct-to-Consumer Broadcast Advertising Policy, Food, Drug, Cosmetic and Medical Device Law Digest, Vol. 15, No. 1
Outside Publications | Article
Kathleen Sanzo

November 1997 New FDA Regulations Implementing the Dietary Supplement Health and Education Act of 1994, Legal Mind, Vol. 164, Japan
Outside Publications | Article
Kathleen Sanzo

05/22/97 Voluntary Standards for Consumer Products - An Antitrust Checklist, presented to the American Bar Association, Section of Administrative Law and Regulatory Practice, Washington, D.C.
Presentation | Speech
Kathleen Sanzo

April 1997 Developments Affecting FDA-Regulated Industries
LawFlash/Client Alert | FDA-Healthcare Regulation LawFlash
FDA/Healthcare Regulation

02/01/97 European Union Proposed Legislation to Encourage Development of Orphan Drug Products
White Paper | Morgan Lewis White Paper
Jill B. Deal

Historic ground will be broken early this spring when the Council and the Parliament of the European Union (EU) introduce legislation that, if passed, will provide significa... more

1997 Capitation: The Legal Implications of Using Capitation to Affect Physician Decision-Making Processes, The Journal of Contemporary Health Law and Policy, Vol. 13
Outside Publications | Article
Andrew Ruskin

November 1996 U.S. Product Liability and Preemption Under the Medical Device Amendments: The Business Implications of the Supreme Court's Medtronic Decision, Legal Mind, Vol. 152, Japan
Outside Publications | Article
James Pagliaro, Kathleen Sanzo

09/17/96 Regrouping and Responding After a Failed New Drug Pre-Approval Inspection by the FDA, presented at the Conference for the Institute for International Research, Philadelphia
Presentation | Speech
Kathleen Sanzo

08/01/96 Product Liability and Preemption Under the Medical Device Amendments: The Business Implications of Medtronic, Inc. v. Lohr
White Paper | Morgan Lewis White Paper
James Pagliaro, Kathleen Sanzo

In a decision that will have a substantial impact on common law-based state product liability cases involving medical devices, and potentially other types of products as well, the U.S. Supreme Court, in Medtron... more

01/01/96 Impact of the Lobbying Disclosure Act of 1995 On Trade Associations
White Paper | Morgan Lewis White Paper
Caswell Hobbs, M. Elizabeth Bierman

On December 19, President Clinton signed into law the Lobbying Disclosure Act of 1995, which significantly alters the lobbying registration and reporting requirements that have been in effect since 1946. The ne... more

1996 Recalls of Consumer Products in U.S. Distribution, Product Safety (First Edition) (London)
Outside Publications | Article
Kathleen Sanzo

1996 Unbridled Managed Care: When Consumers Experience Antitrust Welfare Loss From Exclusionary Contracts Between HMO Insurers and Health Care Providers, Health Matrix, Vol. 6
Outside Publications | Article
Andrew Ruskin

12/01/95 The Lobbying Disclosure Act of 1995
White Paper | Morgan Lewis White Paper
M. Elizabeth Bierman, John Daniel

On December 19, President Clinton signed into law the Lobbying Disclosure Act of 1995, which significantly amends the lobbying registration and reporting requirements that have been in effect since 1946. The ne... more

05/23/95 Anticipating Future Litigation: The Defendant-Plan, presented at the Seventeenth Annual Labor and Employment Law Seminar for Health Care Providers, Wildwood Conference Center, Harrisburg Area Community College, Harrisburg
Presentation | Speech
Health Care Practice Group

05/23/95 Recent Supreme Court Decisions and the Effects of Past Decisions, presented at the Seventeenth Annual Labor and Employment Law Seminar for Health Care Providers, Wildwood Conference Center, Harrisburg Area Community College, Harrisburg
Presentation | Speech
Health Care Practice Group

05/23/95 Violence in the Workplace, presented at the Seventeenth Annual Labor and Employment Law Seminar for Health Care Providers, Wildwood Conference Center, Harrisburg Area Community College, Harrisburg
Presentation | Speech
Health Care Practice Group

April 1994 Legal Considerations in Agreements for Manufacturing and Distribution of Biotechnology Products, Legal Mind (Japan), Vol. 121
Outside Publications | Article
Kathleen Sanzo

03/01/94 Reinvigorated Regulation of Consumer Product Safety Commission Expected with Confirmation of New Chair: ML&B White Paper
White Paper | Morgan Lewis White Paper
Kathleen Sanzo

02/13/94 The Relationship Between Product Tampering and Product Liability, presented at Closure Manufacturers Association Annual Meeting, Washington, D.C.
Presentation | Speech
Kathleen Sanzo

02/01/94 New EC System for Regulating Pharmaceuticals Begins Operations on January 1, 1995: ML&B White Paper
White Paper | Morgan Lewis White Paper

01/18/94 Coordinated Care Organizations, presented at ML&B Nonprofit Health Care Seminar, Philadelphia
Presentation | Speech
Daniel W. Krane, Charles L. O'Brien

12/01/93 European Community Medical Devices Directive: ML&B White Paper
White Paper | Morgan Lewis White Paper

11/08/93 Checklist of Legal Considerations in Agreements for Manufacturing and Distribution of Biotechnology Products, presented at the Biotechnology and Business Conference, Prague, Czech Republic
Presentation | Speech
Kathleen Sanzo

10/01/93 New EC Requirements and Procedures for Pharmaceutical Products: ML&B White Paper
White Paper | Morgan Lewis White Paper

September 1993 The Admissibility of 'Junk Science' Evidence: Regulatory Effects, Regulatory Affairs Professionals Society News
Outside Publications | Article
Kathleen Sanzo

09/01/92 New Federal Reporting Regulations for Consumer Products: ML&B White Paper
White Paper | Morgan Lewis White Paper
Caswell Hobbs, Kathleen Sanzo

08/01/92 Environmental Marketing Claims: ML&B White Paper
White Paper | Morgan Lewis White Paper
Caswell Hobbs, M. Elizabeth Bierman, Michael Clayton

11/01/91 Consumer Product Defects -- New Federal Reporting Obligations Concerning Product Liability Lawsuits and Injuries Caused By Consumer Products: ML&B White Paper
White Paper | Morgan Lewis White Paper
Caswell Hobbs, Kathleen Sanzo

01/01/91 New Federal Reporting Obligations Concerning Defects in Consumer Products: ML&B White Paper
White Paper | Morgan Lewis White Paper
Caswell Hobbs, Kathleen Sanzo

August 1990 Product Liability Considerations Applicable To Pharmaceuticals Marketed In The United States, Legal Mind (Japan), Vol. 78
Outside Publications | Article
M. Elizabeth Bierman

June 1990 U.S. Product Liability Considerations For Exposure To Pesticides From Food, Legal Mind (Japan), Vol. 76
Outside Publications | Article
Kathleen Sanzo

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