Drug Safety Oversight Board Meeting: March 20, 2008 Public Summary
- The acting Executive Director updated the Board on recent communications including Healthcare Professional Sheets and Public Health Advisories (PHAs) posted since the last meeting regarding the drugs:
- Tiotropium bromide (marketed as Spiriva) and Formoterol fumarate (marketed as Foradil)
- Hydrocodone (marketed as Tussionex Pennkinetic Extended Release Suspension)
The safety related communications listed above were announced through MedWatch, CDER’s audio Podcasts and under News from CDER on CDER's home page.
- The Board discussed the development of a pilot program for sharing and exchanging safety communications with other government healthcare organizations.
- The Board heard an update on the status of heparin.
- Finally, the Board reviewed data from and discussed issues on communicating information about a recently completed chemoprevention trial.