Volume 28 - Number 9 | March 2010
| March Issue in PDF Format … |
| CPSC Poised to Implement Online Product Hazard Database By Victor E. Schwartz and Cary Silverman The CPSC is posed to unveil its own online reporting system and public database of actual and potential product hazards. Unless the CPSC implements adequate safeguards, information disseminated through the new online database may be wholly unverified. |
| Practice Tip: FDA Issues Draft Guidance for REMS By Alan G. Minsk and Lanchi Nguyen On Sept. 30, 2009, the FDA issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics. |
| MA Recognizes Medical Monitoring Based on Exposure to Cigarette Smoke By David R. Geiger The Massachusetts Supreme Judicial Court ("SJC") has recognized a cause of action for the projected costs of medical monitoring when a product has not caused any actual disease or illness but solely subclinical physiological changes associated with an increased risk of disease. The decision will have broad implications for product manufacturers and sellers. |
