Home » FDA Is Serious About Postmarket Safety and Monitoring
FDA Is Serious About Postmarket Safety and Monitoring
May 6, 2010
Nowhere is such a systemic, cross-functional monitoring and evaluation program more critical than in the postapproval stage, when finished products are
distributed and sold to healthcare providers and patients. The Food and Drug Administration Amendments Act (FDAAA) has as its strongest provision Title
IX – Enhanced Authorities Regarding Postmarket Safety of Drugs.