Navigate the complex world of US FDA regulations with ‘FDA Regulatory Affairs: Third Edition’. This essential guide, a must-have for pharmaceutical, biotech, and medical device professionals, offers a clear, jargon-free roadmap to product development, compliance, and approval in the United States. Explore the intricacies of prescription drugs, biologics, and medical devices, demystifying the FDA’s processes from clinical trials to market entry. This updated edition covers harmonization with international standards, new drug applications (NDA), cGMPs, GCPs, and recent updates from FDASIA and PDUFA V. Featuring insights from FDA, NIH, and PAREXEL experts, it’s your comprehensive resource for understanding FDA inspections, enforcement, and successful submissions. Perfect for both industry professionals and academics seeking clarity on FDA product approval.