Perspective: Evaluating Regulator Risk for Comparator Drug Products

Posted 01 May 2011 | By Cesar Medina, MBA, RAC Ferno Alvarez-Nunex, PhD 

Evaluating risks and developing mitigation strategies have become common industry practices in drug development. Regulatory agencies have adopted risk-based approaches in quality management, pharmaceutical development and postmarket surveillance of medicinal products.1-4

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