Drug Safety Oversight Board Meeting: April 19, 2007 Public Summary
- The Executive Director updated the Board on Information Sheets and Public Health Advisories (PHAs) posted on CDER’s Drug Safety “Safety Information for Specific Drugs” page since the previous meeting, on March 1, 2007, for the following drugs:
- Tegaserod (Zelnorm)
- Pergolide (Permax)
- Linezolid (Zyvox)
- Interferon gamma 1b (Actimune)
- Erythropoiesis Stimulating Agents (Procrit, Epogen and Aranesp)
New and updated Information Sheets, PHAs, and other safety information were announced through MedWatch, FDA Patient Safety News, CDER’s audio Podcast and under News from CDER at: CDER's home page
- The Board was presented with a proposal from the Fentanyl Working Group regarding next steps in investigating the performance of fentanyl transdermal systems.
- The Board heard a presentation from CDER’s Office of Counter Terrorism and Emergency Coordination, regarding the implementation of the “Animal Rule” [New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are not Ethical or Feasible]
- The Board discussed its potential role in helping to implement the recommendations provided in FDAs response to the IOM report.
- An overview of the Gadolinium-based contrast agents currently marketed in the U.S. was presented to the Board. The labeling for these products with regards to the occurrence of Nephrogenic Systemic Fibrosis (NSF) in patients with severe renal impairment was reviewed.