View Rule

The proposed rule would modernize FDA’s regulations on postmarketing safety reporting and pharmacovigilance for human drug and biological products by capturing important new safety-related information, improving the quality and utility of submitted reports, and supporting enhanced efficiency and alignment with internationally harmonized reporting guidelines.  The proposed rule also would require application holders for drug products and biological products (other than blood or blood components) to establish and maintain a pharmacovigilance quality system that reflects the application holder’s unique needs and that would support the more streamlined, flexible approach to fulfilling certain postmarketing safety reporting requirements