| Date |
Title |
Publication |
| 08/09/1108/09/11 |
FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications
View LawFlash
|
Life Sciences and Healthcare LawFlash |
| 07/28/1107/28/11 |
New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions
View LawFlash
|
Life Sciences and Healthcare LawFlash |
| 05/23/11May/June 2011 |
FDA Issues Final Rule for Medical Device Data Systems, Classifying Certain Health IT Products, FDLI Update
View Article
|
Article |
| 02/15/1102/15/11 |
New FDA Rule on Data Systems Has Implications for Device Manufacturers,
Health IT Developers, and Healthcare Providers
View LawFlash
|
FDA and Healthcare LawFlash |
| 01/19/1101/19/11 |
FDA Preserves 510(k) Pathway; Announces Initial Modifications in Reform Program
View LawFlash
|
FDA and Healthcare LawFlash |
| 12/03/1012/03/10 |
IRS Requests Comments on New Medical Device Excise Tax
View LawFlash
|
FDA and Healthcare LawFlash |
| 08/13/1008/13/10 |
FDA Issues Recommendations on 510(k) Reform and Use of Science in Regulatory Decision Making
View LawFlash
|
FDA and Healthcare LawFlash |
| 04/13/1004/13/10 |
Healthcare Reform Law Imposes New Tax and Other Requirements for Device Manufacturers
View LawFlash
|
Washington Government Relations and Public Policy LawFlash |
| 05/29/09May/June 2009 |
State Regulation of Medical Device Distribution: Strategic Planning Needed to Address Varying Requirements, FDLI Update
View Article
|
Article |
| 05/01/09May 2009 |
FDA and Health IT—As Role of Health IT Gains New Significance, Regulators Will Be Keeping Watch, Health Law Analysis
View Article
|
Article |
| 05/30/08May/June 2008 |
Computer and Software Devices: FDA Seeks Framework for Regulation, FDLI's Update
View Article
|
Article |
| 04/25/0804/25/08 |
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
|
Speech |
| 04/17/0704/17/07 |
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.
|
Speech |
| 01/01/9601/01/96 |
Impact of the Lobbying Disclosure Act of 1995 On Trade Associations
View White Paper
|
White Paper |
| 12/01/9512/01/95 |
The Lobbying Disclosure Act of 1995
View White Paper
|
White Paper |
| 08/01/9208/01/92 |
Environmental Marketing Claims: ML&B White Paper
View Morgan Lewis Title
|
White Paper |
| 08/01/90August 1990 |
Product Liability Considerations Applicable To Pharmaceuticals Marketed In The United States, Legal Mind (Japan), Vol. 78
|
Article |
