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The Drug Approval category features books that explain how medicines move from discovery to patients under the oversight of regulators such as the U.S. FDA and Europe’s EMA. Titles cover the full pathway—preclinical research, clinical trial phases, submissions (e.g., IND, NDA/BLA), chemistry, manufacturing and controls (CMC), benefit–risk assessment, labeling, and post‑market safety (pharmacovigilance). Readers will find practical guides to regulatory strategy and compliance, case studies of successful and failed approvals, discussions of expedited pathways and biosimilars, and analyses of ethics, policy, and market access. Suitable for students and professionals in pharma, biotech, and healthcare, these books blend science, law, and project management to illuminate how safe, effective drugs reach the market worldwide.

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