A complete practitioner's treatment of Food and Drug Administration regulation across all four major product categories, for regulatory counsel, life sciences transactional lawyers, and litigators. Parts I and II establish the jurisdictional framework, the intended use doctrine, and the adulteration and misbranding provisions that all enforcement runs through. Parts III through V cover drugs and biologics: the IND and clinical trial framework, the NDA, ANDA, 505(b)(2), and biologics pathways including Hatch-Waxman and biosimilar exclusivity, labeling and REMS, and promotion including off-label speech after Caronia and Amarin. Part VI covers devices from classification through 510(k), De Novo, and PMA, with the quality system, reporting, and software provisions. Parts VII and VIII cover food and dietary supplements including FSMA preventive controls, GRAS, DSHEA notification and claim rules, and cosmetics as changed by MoCRA. Parts IX through XII cover manufacturing and supply chain requirements, recalls and field actions, the enforcement ladder through consent decrees and the responsible corporate officer doctrine, and preemption across the categories. Part XIII covers transactional diligence and Part XIV is the verification list.