Practice Areas
- Life Sciences
- Antitrust
- FDA & Healthcare
- Mergers & Acquisitions / Premerger Notification
- General Counseling & Distribution
- Pharmaceuticals & Biologics
- Foods & Dietary Supplements
- Regulated Industries
- Government & Private Antitrust Litigation & Investigations
- Private Equity
- Private Equity M&A
- Latin America
- Advertising, Consumer Protection, & Privacy
Bar Admissions
- District of Columbia
- Washington, D.C.
-
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5205
Fax: 202.739.3001
65 Publications Found
| Date | Title | Publication |
| 04/22/10 |
How Regulatory Structures are Taking into Account Scientific Developments in Assessing Approved Food Contact Products, presented at the 2010 Food and Drug Law Institute
Annual Conference, Washington, D.C. 
View Presentation
|
Speech |
| 04/19/10 |
Healthcare Reform Law: Comparative Effectiveness Provisions Concerning Healthcare Products and Services
View LawFlash
|
Washington Government Relations and Public Policy LawFlash |
| November/December 2009 |
21st Century Toxicology and its Implications for FDA Regulation of Food-Contact Substances, FDLI Update
View Article
|
Article |
| 10/01/09 |
New Trends Affecting Pharmaceutical and Medical Device Life Cycle Risk Management, presented at the Fourth National FDA Regulatory Symposium, Washington, D.C.
View Presentation
|
Speech |
| 07/16/09 |
Detecting Off-Label Promotion Issues That Can Derail a Life Sciences M&A, presented at ACI's 6th Annual Pharmaceutical Counsel's Guide to Off-Label Communications, Philadelphia
View Presentation
|
Speech |
| 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. |
Speech |
| 03/13/08 |
Critical Regulatory Concerns that Must be Addressed in a Life Sciences M&A, presented at the American Conference Institute, New York
View Presentation
|
Speech |
| 2008 |
The Centrality of Regulatory Due Diligence in Life Sciences M&A (Chapter 2), Life Sciences Mergers and Acquisitions (Aspatore Books) |
Chapter |
| 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
View Presentation
|
Speech |
| 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
View Presentation
|
Speech |
| 06/18/07 |
New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25
View Article
|
Article |
| 04/13/07 |
Panel Discussion with the Director of the FDA Center for Drug Evaluation and Research, presented at the 50th Annual Food and Drug Law Institute/FDA Conference, North Bethesda, MD |
Speech |
| 03/15/07 |
The Six Regulatory Issues That MUST Be Addressed in a Life Sciences M&A, presented to the American Conference Institute, New York
View Presentation
|
Speech |
| 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
View Presentation
|
Speech |
| 2006/07 |
Overview of Healthcare Fraud Investigations in the U.S., PLC Cross-border Life Sciences Handbook 2006/07
View Chapter
|
Chapter |
| 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
View Presentation
|
Speech |
| 06/18/05 |
Starting or Expanding a Pharma/Biotech Business in the U.S.: New Legal and Regulatory Issues, presented at the 6th Annual Philadelphia-Japan Health Sciences Dialogue, Japan America Society, Philadelphia
View Presentation
|
Speech |
| 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. |
Speech |
| November 2004 |
Licensing in the Pharmaceutical Industry: Strategies and Questions Regarding Antitrust Premerger Notification, FDLI Update
View Article
|
Article |
| July/August 2004 |
New Medicare Act Provides New Competitive Landscape for the Pharmaceutical Industry, FDLI Update, Vol. 36
View Article
|
Article |
| 2004 |
Applying Antitrust Law Effectively: The Importance of Simplifying Complexity, Winning Antitrust Strategies (Aspatore Books)
View Chapter
|
Chapter |
| 03/17/04 |
How to Preserve Your Antitrust Immunity for Lobbying and Obtaining State Actions, presented at the Morgan Lewis Trade Association Teleseminar Series |
Speech |
| 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.
View Presentation
|
Speech |
| 01/01/04 |
The Role of Pharmaceutical Licensing in Product Lifecycle Management: Litigation and Settlement Under the Hatch-Waxman Act (Chapter 8), Licensing Deskbook (Loislaw) |
Chapter |
| 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.
View Presentation
|
Speech |