Kathleen M. Sanzo
Email: ksanzo@morganlewis.com
- Washington, D.C.
-
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5209
Fax: 202.739.3001
Publications
| Date | Type | Title |
| 05/02/2012 | Presentation | Update on the Biosimilars Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars, presented at the BioNJ Diamond Circle Board of Trustees Meeting |
| 04/02/2012 | Outside Publication | It’s Not Just Pill Mills The DEA Is After, Law360 |
| 03/09/2012 | LawFlash/Client Alert | Pharmacies and Suppliers Beware: It Is Not Just the Pill Mills They Are After |
| 02/09/2012 | LawFlash/Client Alert | FDA Issues Three Draft Guidances for Biosimilars |
| 01/11/2012 | LawFlash/Client Alert | FDA Gets (Un)Social |
| 2011 | Outside Publication | Co-author, Prescription, Drug Promotions and Marketing, FDLI’s Food and Drug Law Regulation 2011, 2nd edition |
| 05/23/2011 | LawFlash/Client Alert | FDA Requests Comments on the Development of a User Fee Program for Biosimilar and Interchangeable Biological Products |
| 01/07/2011 | LawFlash/Client Alert | FDA Food Safety Modernization Act Summary |
| 12/23/2010 | LawFlash/Client Alert | FDA Food Safety Modernization Act Greatly Expands FDA Enforcement Powers |
| 11/30/2010 | Outside Publication | Utilizing REMS to Mitigate the Safety Risks of Pharmaceuticals: Perspectives on FDA Guidance, Lifecycle Management
and Creating a New Scientific Discipline, FDLI Monograph Series |
| 05/20/2010 | Presentation | Healthcare Reform—New Path for Biosimilars, presented at a Washington Legal Foundation Webcast |
| 05/19/2010 | Presentation | May 2010 Health Care Reform Update, presented at a BioNJ Legal Breakfast Briefing, Bridgewater, NJ |
| 04/26/2010 | Presentation | The Use of Social Media in Promotion of Medical Products, presented at PLI's Health Care 2010: Managing Risks in the New Compliance and Enforcement Environment Conference, New York |
| 04/19/2010 | Presentation | Legal Issues Arising from REMS Programs, presented at the ACI REMS Conference, New York |
| 04/15/2010 | LawFlash/Client Alert | Healthcare Reform Law: A New Regulatory Pathway for Biosimilar Biological Products |
| 04/15/2010 | LawFlash/Client Alert | Healthcare Reform Law: Impact on Pharmaceutical Manufacturers |
| September 2009 | Outside Publication | The Ever-Widening Legal Morass Around Off-Label Communication, Washington Legal Foundation's Contemporary Legal Note Series, No. 63 (click here to read the article) |
| August 2009 | Presentation | Regulatory Considerations and Evolving Issues Concerning REMS Programs |
| 06/18/2009 | Presentation | Life Sciences Summer Series: Drug and Device Off-Label Promotion (a Morgan Lewis Webinar) |
| 03/25/2009 | Presentation | Regulatory and Litigation Strategies for Life Sciences Companies Post-Wyeth v. Levine, presented as a Morgan Lewis Webinar |
| 03/05/2009 | LawFlash/Client Alert | U.S. Supreme Court Ruling in Wyeth v. Levine Rejects Preemption of Failure-to-Warn Claim |
| 11/03/2008 | LawFlash/Client Alert | The Consumer Product Safety Improvement Act of 2008: Deputizing State Attorneys General and Plaintiffs’ Lawyers |
| 06/19/2008 | Presentation | Regulatory and Legal Developments Concerning Clinical Trials, presented at the 2008 BIO International Convention, San Diego, CA |
| 02/19/2008 | Presentation | Negotiating and Living with Consent Decrees, presented at the 6th Annual Food and Drug Law Institute Enforcement and Litigation Conference, Washington, D.C. |
| 01/29/2008 | Presentation | State Perspectives on Existing and Future Regulations Surrounding Sales and Marketing, presented at the 5th Annual Pharmaceutical Marketing Compliance Congress, Washington, D.C. |
| 12/06/2007 | Presentation | 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 |
| 06/19/2007 | Presentation | Proactive Steps Every Provider Should Take to Avoid Government Scrutiny, presented at ACI's Preparing for Government Healthcare Fraud Enforcement Conference, Washington, D.C. |
| 06/18/2007 | Outside Publication | New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25 |
| 05/17/2007 | Presentation | Compliant Models for Medical Device Grants, presented at CBI's Premier West Coast Conference on Bio/Pharmaceutical and Medical Device Grants, San Francisco |
| 05/17/2007 | Presentation | Regulatory and Corporate Considerations in Life Sciences Industry Investments, presented at a Morgan Lewis Seminar, Palo Alto |
| 04/17/2007 | Presentation | The AdvaMed Code of Ethics, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C. |
| 2007 | Outside Publication | Keys to Successful Interactions with Governing Bodies, Inside the Minds: Food and Drug Law Settlements and Negotiations |
| 2006/07 | Outside Publication | Overview of Healthcare Fraud Investigations in the U.S., PLC Cross-border Life Sciences Handbook 2006/07 |
| 07/18/2006 | Presentation | Crossing Paths with the FDA—Regulatory Influence on the Defense of Drug and Device Products, presented at the Defense Research Institute Teleconference |
| 03/29/2006 | Presentation | Generic Drug Issues: Authorized Generics, presented at the Temple University School of Pharmacy FDA/Industry Conference |
| 03/07/2006 | Presentation | The New Medicare Act and Its Effects on Life Sciences Companies, presented to the New Jersey Technology Council Life Sciences Industry Network |
| 2005/06 | Outside Publication | Overview of Healthcare Fraud Investigations in the U.S., PLC Cross-border Life Sciences Handbook |
| July/August 2004 | Outside Publication | New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry, FDLI Update, Vol. 36 |
| 02/28/2003 | Outside Publication | FDA Must Clarify Drug Makers' Ability to Publicly Defend Products, Litigation Legal Foundation Legal Update, Vol. 13, No. 7 |
| 11/04/2002 | Presentation | Navigating a Pathway to FDA Approval |
| 09/06/2002 | Outside Publication | FTC, Not FDA, Should Regulate Online Food Information, Legal Backgrounder, Vol. 17, No. 38 |
| 08/01/2002 | Outside Publication | FDA Challenges to Pharmaceutical Company Control of Product Lifecycle Management, FDLI Update |
| August 2002 | Outside Publication | Market Exclusivity: New Legal Developments and Pharmaceutical Marketing Implications, Regulatory Affairs Focus |
| 04/23/2002 | Presentation | HIPAA: What Medical Device Firms Should Be Doing Now |
| 04/01/2002 | Presentation | Be Wary of HP Lawsuits: Emerging Firms, presented to AvaMed, Washington, D.C. |
| March 2002 | Outside Publication | Pharmaceutical Pricing: System Changes And Global Effects, Metropolitan Corporate Counsel |
| 02/01/2002 | Presentation | Corporate Response to CPSC Challenge - Legal, Technical, and Public Relations Issues, presented at the ICPHSO 9th Annual Meeting of the ABA Product Safety Seminar, Washington, D.C. |
| 2003 | Outside Publication | Consumer Products Regulation (Chapter 13), Developments in Administrative Law and Regulatory Practice 2002-2003 (ABA Section on Administrative Law) |
| August 2001 | Outside Publication | U.S. Pharmaceutical Pricing: System Changes and Global Effects, Life Sciences Industry Report |
| January 2001 | Outside Publication | It's Worse Than You Think: US Regulatory Changes Require Pharmaceutical Company Attention, International Financial Law Review: Competition & Antitrust (Special IFLR Supplement) |
| January 2001 | Morgan Lewis Title | New Proposed Policy Regarding Imposition of Reporting Requirements on Products Sold Outside of the United States |
| 12/01/2000 | Presentation | Regulatory Litigation in the Innovator Pharmaceutical Industry, presented at the FDLI's Conference on Hatch-Waxman: Past, Present and Future, Washington, D.C. |
| November 2000 | Morgan Lewis Title | California Trial Court Finds Ford Acted Fraudulently by Not Reporting Safety Information to Federal Agenices |
| 09/04/2000 | Outside Publication | Expect Big Change in Drug Pricing System, The National Law Journal |
| June 2000 | Outside Publication | Providing Off-Label Use Information: New Decision Sends Industry One-Half Step Back, Regulatory Affairs Focus |
| 02/01/2000 | Presentation | CPSC 15(b) Reporting Requirements: A Practical Guide to Knowing When and What to Report, presented to the American Bar Association, Orlando, FL |
| 11/08/1999 | Presentation | 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. |
| 06/29/1999 | Presentation | Medical Device Update, presented to the Food and Drug Law Institute, Washington, D.C. |
| 12/07/1998 | Outside Publication | Strategies for Obtaining Market Exclusivity for Genetic Discoveries: Patent, FDA, and Contract Mechanisms, Decision Resources, Inc. |
| January 1998 | Outside Publication | 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 |
| November 1997 | Outside Publication | New FDA Regulations Implementing the Dietary Supplement Health and Education Act of 1994, Legal Mind, Vol. 164, Japan |
| 05/22/1997 | Presentation | Voluntary Standards for Consumer Products - An Antitrust Checklist, presented to the American Bar Association, Section of Administrative Law and Regulatory Practice, Washington, D.C. |
| November 1996 | Outside Publication | 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 |
| 09/17/1996 | Presentation | 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 |
| 08/01/1996 | Morgan Lewis Title | Product Liability and Preemption Under the Medical Device Amendments: The Business Implications of Medtronic, Inc. v. Lohr |
| 1996 | Outside Publication | Recalls of Consumer Products in U.S. Distribution, Product Safety (First Edition) (London) |
| April 1994 | Outside Publication | Legal Considerations in Agreements for Manufacturing and Distribution of Biotechnology Products, Legal Mind (Japan), Vol. 121 |
| 03/01/1994 | Morgan Lewis Title | Reinvigorated Regulation of Consumer Product Safety Commission Expected with Confirmation of New Chair: ML&B White Paper |
| 02/13/1994 | Presentation | The Relationship Between Product Tampering and Product Liability, presented at Closure Manufacturers Association Annual Meeting, Washington, D.C. |
| 11/08/1993 | Presentation | Checklist of Legal Considerations in Agreements for Manufacturing and Distribution of Biotechnology Products, presented at the Biotechnology and Business Conference, Prague, Czech Republic |
| September 1993 | Outside Publication | The Admissibility of 'Junk Science' Evidence: Regulatory Effects, Regulatory Affairs Professionals Society News |
| 09/01/1992 | Morgan Lewis Title | New Federal Reporting Regulations for Consumer Products: ML&B White Paper |
| 11/01/1991 | Morgan Lewis Title | Consumer Product Defects -- New Federal Reporting Obligations Concerning Product Liability Lawsuits and Injuries Caused By Consumer Products: ML&B White Paper |
| 01/01/1991 | Morgan Lewis Title | New Federal Reporting Obligations Concerning Defects in Consumer Products: ML&B White Paper |
| June 1990 | Outside Publication | U.S. Product Liability Considerations For Exposure To Pesticides From Food, Legal Mind (Japan), Vol. 76 |