Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)

Section I: General Information
Chapter 1: FDA and Related Regulatory Agencies
Chapter 2: History of Food, Drug and Cosmetic Laws
Chapter 3: Overview of Drug, Biologic, Device, Combination Product or Food Regulatory Pathways
Chapter 4: FDA Communications and Meetings
Chapter 5: Preparing for FDA Advisory Committee Meetings
Chapter 6: Good Laboratory Practice Regulations
Chapter 7: Clinical Trials: GCPs, Regulations and Compliance for Drugs, Biologics and Medical Devices
Chapter 8: Current Good Manufacturing Practices and Quality System Design
Chapter 9: FDA User Fees
Chapter 10: Regulatory Strategy
Chapter 11: Master Protocol
Chapter 12: Traceability and Supply Chain
Chapter 13: Healthcare Fraud and Abuse Compliance

Section II: Drugs
Chapter 14: Prescription Product Drug Submissions
Chapter 15: Postapproval Submissions and Compliance: Prescription Drugs and Biologics
Chapter 16: Generic Drug Submissions
Chapter 17: Patents and Exclusivity
Chapter 18: Over-the-Counter (Nonprescription) Drug Products
Chapter 19: Prescription Drug Labeling, Advertising and Promotion
Chapter 20: Pharmacovigilance and Risk Management

Section III: Medical Devices
Chapter 21: Medical Device Submissions
Chapter 22: Medical Device Compliance and Postmarketing Activities
Chapter 23: In Vitro Diagnostics Submissions and Compliance
Chapter 24: Advertising, Promotion and Labeling for Medical Devices and In Vitro Diagnostics (IVDs)

Section IV: Biologics
Chapter 25: Biologics Submissions
Chapter 26: Biologics Compliance
Chapter 27: Biosimilars
Chapter 28: Biologics Labeling, Advertising and Promotion
Chapter 29: Blood and Blood Products
Chapter 30: Regulating Cell & Gene Therapies, Genetically Modified Cells and Devices in Regenerative Medicine

Section V: Foods
Chapter 31: Food Products
Chapter 32: Dietary Supplements and Homeopathic Products
Chapter 33: Medical Foods

Section VI: Other Product Classifications
Chapter 34: Combination Products
Chapter 35: Products for Small Patient Populations
Chapter 36: Human Cell and Tissue Products
Chapter 37: Pediatric Drug and Device Development

Section VII: Inspection and Enforcement
Chapter 38: FDA Inspection and Enforcement

Section VIII: Resources
Chapter 39: Regulatory Information Resources in Review

General chapters cover such topics as the history of US regulation, FDA meetings, user fees, regulatory strategy, healthcare fraud and abuse and traceability. Specific sections discuss product development through postmarket compliance. Other chapters address orphan drugs, foods, blood products and those derived from blood as well as tissue and cellular products.