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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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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.