Comprehensive taxonomy of therapeutic areas used by FDA, EMA, and Health Canada for regulatory classification. Use this guide to filter and organize regulatory updates relevant to your specialty.
Regulatory Focus: Oncology Division, FDA CDER; EMA CHMP Oncology Working Party
Key Guidance: FDA Guidance on Cancer Clinical Trials, EMA Oncology Guidelines
Regulatory Focus: Division of Cardiology and Nephrology, FDA CDER
Key Guidance: Cardiovascular Safety Guidance, Diabetes Drug Development Guidance
Regulatory Focus: Division of Neurology, Division of Psychiatry, FDA CDER
Key Guidance: CNS Drug Development Guidance, Alzheimer's Disease Guidance
Regulatory Focus: Division of Anti-Infectives, FDA CDER; EMA Infectious Diseases Working Party
Key Guidance: Antibacterial Drug Development Guidance, Antiviral Drug Development
Regulatory Focus: Division of Pulmonology, Allergy, and Rheumatology, FDA CDER
Key Guidance: Asthma Drug Development, Rheumatology Guidance
Regulatory Focus: Office of Orphan Products Development, FDA; EMA Orphan Medicines
Key Guidance: Orphan Drug Designation, Rare Disease Endpoint Guidance
Regulatory Focus: FDA CBER (Center for Biologics Evaluation and Research)
Key Guidance: Vaccine Development Guidance, mRNA Vaccine Guidance
Regulatory Focus: Office of Tissues and Advanced Therapies, FDA CBER; EMA CAT
Key Guidance: Gene Therapy Guidance, CAR-T Cell Therapy Guidance
Regulatory Focus: Pediatric Review Committee, FDA; EMA Paediatric Committee
Key Guidance: Pediatric Study Plans, Extrapolation in Pediatric Drug Development
Regulatory Focus: Division of Bone, Reproductive and Urologic Products, FDA CDER
Key Guidance: Pregnancy and Lactation Labeling, Women's Health Drug Development
Regulatory Focus: Division of Cardiology and Nephrology, FDA CDER
Key Guidance: CKD Drug Development Guidance
Regulatory Focus: Division of Transplant and Ophthalmology Products, FDA CDER
Key Guidance: Ophthalmic Drug Development Guidance
Regulatory Focus: Division of Dermatology and Dentistry, FDA CDER
Key Guidance: Dermatologic Drug Development Guidance
Regulatory Focus: Division of Gastroenterology, FDA CDER
Key Guidance: IBS Drug Development, NASH Drug Development Guidance
Regulatory Focus: Division of Anesthesia, Analgesia, and Addiction Products, FDA CDER
Key Guidance: Opioid Analgesic REMS, Non-Opioid Pain Drug Development
Use therapeutic areas to filter FDA guidance documents, EMA opinions, and Health Canada notices. Focus only on updates relevant to your products and pipeline.
Set up alerts and dashboards based on therapeutic areas. For example, if you work in oncology, track FDA Oncology Division updates, EMA CHMP Oncology Working Party opinions, and cancer-related guidance.
Each therapeutic area maps to specific FDA divisions and EMA working parties. Understanding this structure helps you target your monitoring efforts and anticipate which teams will review your submissions.
Different therapeutic areas have different guidance update cycles. Use this taxonomy to monitor draft guidance publications, public comment periods, and final guidance releases in your areas.
RegulatoryAlerts automatically filters FDA, EMA, and Health Canada updates by therapeutic area. Get only the updates that matter to your products—no manual filtering required.
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