Drug Safety Debate: Top Three Reform Initiatives in 2005




About the Authors
**photo-1**Debra S. Dunne, Esq
. is a partner at Segal McCambridge Singer & Mahoney, Ltd. in the Philadelphia office. She is a pharmacist and attorney with leading clients in the pharmaceutical and medical device industries. Her FDA regulatory practice includes counseling clients on FDCA, FDAMA, and other FDA and industry guidances, including OIG guidance documents, the PhRMA Code and AdvaMed Code of Ethics. Ms. Dunne's experience includes addressing various off label promotion issues, risk analysis, and planning of company drug promotion, publication and independent medical education strategies. She also develops Comprehensive Compliance Programs consistent …





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