M. Elizabeth Bierman
Email: mebierman@morganlewis.com
- Washington, D.C.
-
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5206
Fax: 202.739.3001
Publications
| Date | Type | Title |
| 08/09/2011 | LawFlash/Client Alert | FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications |
| 07/28/2011 | LawFlash/Client Alert | New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions |
| May/June 2011 | Outside Publication | FDA Issues Final Rule for Medical Device Data Systems, Classifying Certain Health IT Products, FDLI Update |
| 02/15/2011 | LawFlash/Client Alert | New FDA Rule on Data Systems Has Implications for Device Manufacturers,
Health IT Developers, and Healthcare Providers |
| 01/19/2011 | LawFlash/Client Alert | FDA Preserves 510(k) Pathway; Announces Initial Modifications in Reform Program |
| 12/03/2010 | LawFlash/Client Alert | IRS Requests Comments on New Medical Device Excise Tax |
| 08/13/2010 | LawFlash/Client Alert | FDA Issues Recommendations on 510(k) Reform and Use of Science in Regulatory Decision Making |
| 04/13/2010 | LawFlash/Client Alert | Healthcare Reform Law Imposes New Tax and Other Requirements for Device Manufacturers |
| May/June 2009 | Outside Publication | State Regulation of Medical Device Distribution: Strategic Planning Needed to Address Varying Requirements, FDLI Update |
| May 2009 | Outside Publication | FDA and Health IT—As Role of Health IT Gains New Significance, Regulators Will Be Keeping Watch, Health Law Analysis |
| May/June 2008 | Outside Publication | Computer and Software Devices: FDA Seeks Framework for Regulation, FDLI's Update |
| 04/25/2008 | Presentation | 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 |
| 04/17/2007 | Presentation | 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. |
| 01/01/1996 | Morgan Lewis Title | Impact of the Lobbying Disclosure Act of 1995 On Trade Associations |
| 12/01/1995 | Morgan Lewis Title | The Lobbying Disclosure Act of 1995 |
| 08/01/1992 | Morgan Lewis Title | Environmental Marketing Claims: ML&B White Paper |
| August 1990 | Outside Publication | Product Liability Considerations Applicable To Pharmaceuticals Marketed In The United States, Legal Mind (Japan), Vol. 78 |