Pharmaceutical Regulatory Process

Overview

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

New Chapters Cover

the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance

pharmacovigilance programs designed to prevent widespread safety issues

legal issues surrounding the sourcing of foreign APIs

the issues of counterfeit drugs and, updates on quality standards.