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Drug Safety Oversight Board Meeting
July 12, 2007 Public Summary
- The Executive Director updated the Board on Information Sheets and Public Health Advisories (PHAs) posted since the last meeting regarding the drugs:
- Gadolinium-containing contrast agents (MultiHance, Omniscan, Magnevist, Prohance, OptiMARK)
- Propofol (Diprivan and generic products)
- Colistimethate (Coly-Mycin M and generic products)
- Omalizumab (Xolair)
- The new and updated information for healthcare professionals sheets, PHAs and other safety information were announced through MedWatch, CDER’s audio Podcasts and under News from CDER at http://www.fda.gov/cder/index.html
- The Board received updates about ongoing topics including providing information to healthcare professionals on use of over-the counter cough and cold medicines in children.
- The Board discussed the following:
- The actions FDA could take to better inform physicians about the appropriate prescribing practices for fentanyl transdermal patches.
- The use of disclaimers on FDA’s Healthcare Provider (HCP) sheets
- An early draft of a document outlining CDER’s principles for risk-based decision making.
- The Board heard a presentation from the Safety Policy and Communications Staff about the ongoing risk communication strategic planning effort.
- The Board heard a presentation of a recent emerging, potential safety issue, which served as the basis for the continuing safety communication policy discussion.
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Date created: August 10, 2007
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