Module 5 Presentations

18/07/2024

FDA Organization

Center for Drug Evaluation and Research (CDER) includes:

Office of New Drugs: - Provide regulatory oversight for investigational studies during drug development. - Make decisions regarding marketing approval for new (innovator or non-generic) drugs - Provide guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters, to achieve the common goal of more efficient drug development. Includes, 8 review offices (noted below) overseeing 27 review divisions: ● Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) – Cardiology and Nephrology, Diabetes, Lipid Disorders and Obesity, General Endocrinology and Nonmalignant Hematology ● Office of Immunology and Inflammation (OII) – Dermatology and Dentistry, Gastroenterology, Hepatology and Nutrition, Pulmonology, Allergy and Critical Care, Rheumatology and Transplant Medicine. ● Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPRUM) – Pediatric and Maternal Health, Rare Diseases and Medical Genetics, Urology, Obstetrics and Gynecology. ● Office of Infectious Diseases (OID) – anti-infective products, antiviral products, transplant and ophthalmology products. ● Office of Neuroscience – neurology products, psychiatric products, anesthesia, analgesia and addiction products. ● Office of Nonprescription Drugs (ONPD) – nonprescription products (marketed as over-the-counter (OTC) monographs and as NDAs) ● Office of Oncologic Diseases (OOD)- oncology products, non-malignant hematology products, and issues related to hematology, oncology, toxicology ● Office of Specialty Medicine (OSM) – Drug product used in the image-based diagnosis and monitoring of diseases as well as ophthalmology products.

The Organisation for Professionals in Regulatory Affairs

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FDA Organization

Center for Biologics Evaluation and Research (CBER), includes:

• Office of Blood Research and Review

• Office of Vaccines Research and Review

• Office of Therapeutic Products

The Organisation for Professionals in Regulatory Affairs

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