Risk evaluation and mitigation strategies – the impact on practitioners
- At: 2010 FIP Congress in Lisbon (Portugal)
- Type: Presentation
- By: CHEN, David (American Society of Health-System Pharmacists, Bethesda, United States of America)
The FDA in its pursuit to improve drug safety in the United States has enhanced post marketing surveillance and has implemented Risk Evaluation and Mitigation Strategies (REMS) for medications with actual or potential safety concerns. It is through the Food and Drug Administration Amendments Act (FDAAA) of 2007 which grants the FDA new authorities.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.