The Pharmaceutical Regulatory Process

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. medical marketing, active pharmaceutical ingredients, pharmaceutical development, pure food, critical path initiative, centennial book, container closure system, therapeutic equivalence evaluations, postapproval regulatory affairs, reference listed drug, applications without data, drug application sponsor, involving reverse payments, new drug definition, new drug provisions, supplements with data, foreign drug manufacturers, creating new section, clinical research requirements, generic applicant, drug exclusivity, suitability petition, first filer, pediatric exclusivity, prior approval supplement