Morgan Lewis

Related Publications

02/09/12 FDA Issues Three Draft Guidances for Biosimilars
Initial guidance provides insights on regulatory pathway for biosimilars, but does not address many critical issues.
01/11/12 FDA Gets (Un)Social
FDA draft guidance on responding to requests for off-label information foreshadows restrictive policies on use of social media.
05/23/11 FDA Requests Comments on the Development of a User Fee Program for Biosimilar and Interchangeable Biological Products
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Related News

05/28/10 Attorneys See Uncertainty in FDA's Implementation of Biosimilar Approvals, Life Sciences Law & Industry Report
09/24/09 Morgan Lewis Advises LEO Pharma on $1 Billion Acquisition
Morgan Lewis represented LEO Pharma in the $1 billion acquisition of exclusive product licensing rights and inventories from LEO Pharma by Warner Chilcott plc.
12/20/06 Morgan Lewis's Life Sciences Practice Recognized in PLCCross-border Life Sciences Handbook
Morgan Lewis is pleased to announce that the Life Sciences Interdisciplinary Practice and several of its attorneys are recognized in the PLCCross-border Life Sciences Handbook 2006/07.
View all news
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Kathleen M. Sanzo

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Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5209
Fax: 202.739.3001

71 Publications Found
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Date Title Publication
02/09/1202/09/12 FDA Issues Three Draft Guidances for Biosimilars

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Life Sciences and Healthcare LawFlash
01/11/1201/11/12 FDA Gets (Un)Social

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Life Sciences and Healthcare LawFlash
05/23/1105/23/11 FDA Requests Comments on the Development of a User Fee Program for Biosimilar and Interchangeable Biological Products

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Life Sciences and Healthcare LawFlash
01/07/1101/07/11 FDA Food Safety Modernization Act Summary

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FDA and Healthcare LawFlash
12/23/1012/23/10 FDA Food Safety Modernization Act Greatly Expands FDA Enforcement Powers

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FDA and Healthcare LawFlash
11/30/1011/30/10 Utilizing REMS to Mitigate the Safety Risks of Pharmaceuticals: Perspectives on FDA Guidance, Lifecycle Management and Creating a New Scientific Discipline, FDLI Monograph Series


 Article
05/20/1005/20/10 Healthcare Reform—New Path for Biosimilars, presented at a Washington Legal Foundation Webcast

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Speech
05/19/1005/19/10 May 2010 Health Care Reform Update, presented at a BioNJ Legal Breakfast Briefing, Bridgewater, NJ

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Speech
04/26/1004/26/10 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

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Speech
04/19/1004/19/10 Legal Issues Arising from REMS Programs, presented at the ACI REMS Conference, New York

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Speech
04/15/1004/15/10 Healthcare Reform Law: A New Regulatory Pathway for Biosimilar Biological Products

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Washington Government Relations and Public Policy LawFlash
04/15/1004/15/10 Healthcare Reform Law: Impact on Pharmaceutical Manufacturers

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Washington Government Relations and Public Policy LawFlash
09/01/09September 2009 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)


 Article
08/01/09August 2009 Regulatory Considerations and Evolving Issues Concerning REMS Programs

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Speech
06/18/0906/18/09 Life Sciences Summer Series: Drug and Device Off-Label Promotion (a Morgan Lewis Webinar)

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Webinar
03/25/0903/25/09 Regulatory and Litigation Strategies for Life Sciences Companies Post-Wyeth v. Levine, presented as a Morgan Lewis Webinar


 Webinar
03/05/0903/05/09 U.S. Supreme Court Ruling in Wyeth v. Levine Rejects Preemption of Failure-to-Warn Claim

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Litigation LawFlash
11/03/0811/03/08 The Consumer Product Safety Improvement Act of 2008: Deputizing State Attorneys General and Plaintiffs’ Lawyers

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Litigation LawFlash
06/19/0806/19/08 Regulatory and Legal Developments Concerning Clinical Trials, presented at the 2008 BIO International Convention, San Diego, CA


 Speech
02/19/0802/19/08 Negotiating and Living with Consent Decrees, presented at the 6th Annual Food and Drug Law Institute Enforcement and Litigation Conference, Washington, D.C.


 Speech
01/29/0801/29/08 State Perspectives on Existing and Future Regulations Surrounding Sales and Marketing, presented at the 5th Annual Pharmaceutical Marketing Compliance Congress, Washington, D.C.


 Speech
12/06/0712/06/07 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


 Speech
06/19/0706/19/07 Proactive Steps Every Provider Should Take to Avoid Government Scrutiny, presented at ACI's Preparing for Government Healthcare Fraud Enforcement Conference, Washington, D.C.


 Speech
06/18/0706/18/07 New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25

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Article
05/17/0705/17/07 Compliant Models for Medical Device Grants, presented at CBI's Premier West Coast Conference on Bio/Pharmaceutical and Medical Device Grants, San Francisco


 Speech
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