Biotech Business
2008 Brings New FDA Post-Market Requirements That Demand Expert Services, Reports Watermark Research Partners
Published in Drug Law Weekly, January 22nd, 2008
In an effort to better protect consumers, the Food and Drug Administration Amendments Act of 2007 (FDAAA) delivers expanded authority to the U.S. Food and Drug Administration (FDA) and commands comprehensive, objective post-market safety and risk-mitigation activities from pharmaceutical, biotech, and medical device companies. Due to the enormity of the new requirements, sponsors seeking to avoid negative consequence and gain competitive edge are looking to independent, highly qualified medical service providers for critical support.
Signed into law September 27, 2007 and effective in 2008 and beyond, the FDAAA revises the Federal Food Drug and Cosmetic Act (FDCA) to...
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Source: Drug Law Weekly (2008-01-22)
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