Course Syllabus

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I. Introduction to FDA

January 3: History of food and drug regulation, history of the FDA, structure of statute. Reading: Hutt & Merrill Chapter I.

II. Jurisdiction and Enforcement

January 4: Prohibited acts, jurisdiction, factory inspection, judicial enforcement, informal enforcement. Reading: Hutt & Merrill pages 1040-1046, 1057-1069, 1075-1079, 1081-1082, 1087-1093, 1104-1107, 1118, 1125-1127, 1133-1134, 1136-1141, 1150-1160, 1171, 1175-1182, 1187-1189, 1194-1197, 1205-1206, 1217-1218, 1227, 1233-1235.

III. Regulation of Human Food

January 5: Definition, labeling. Reading: Hutt & Merrill pages 23-32, 36-45, 48-55, 59-60, 79-92, 96-101, 103-104, 113-119, 121-123, 126-127, 129-130.

January 6: Nutrient content. Reading: Hutt & Merrill pages 135-142, 144-153, 156-169, 175-176, 180-203.

January 7: Sanitation, safety. Reading: Hutt & Merrill pages 228-237, 240-241, 246-262, 269-271, 283-300, 304-306, 311-313, 316-327, 332-334, 342-348, 376-377.

IV. Regulation of Human Drugs

January 10: Definition, labeling, advertising, good manufacturing practices. Reading: Hutt & Merrill pages 378-384, 388-393, 397-407, 411-421, 29-438, 444-446, 452, 462-466, 468-469.

January 11: Investigational new drugs, new drug applications, postmarketing regulation, the AIDS revolution. Reading: Hutt & Merrill pages 475-487, 496-499, 506-508, 510-543, 552-566, 571-574, 580-588.

January 12: Control of prescribing, regulation of OTC drugs. Reading: Hutt & Merrill pages 616-635, 588-616.

V. Regulation of Animal Feed and Drugs

January 13: Animal feed, animal drugs. Reading: Hutt & Merrill Chapter IV.

VI. Regulation of Human Biological Drugs and Biotechnology

January 14: Biologics, blood, organs and tissues, immunization, biotechnology. Reading: Hutt & Merrill Chapters V & IX.

VII. Regulation of Human Medical Devices

January 18: Definition, labeling, the 1976 Amendments. Reading: Hutt & Merrill pages 720-753.

January 19: Substantial equivalence, pre-market approval, post-market regulation, radiation devices, technology assessment. Reading: Hutt & Merrill pages 754-811.

VIII. Regulation of Human Cosmetics and Color Additives

January 20: Definition, adulteration, misbranding, voluntary regulation, hair dyes, color additives. Reading: Hutt & Merrill Chapter VII, pages 357-376.

IX. Regulation of Carcinogens

January 21: History, Delaney clause, DES, risk assessment, secondary carcinogens. Reading: Hutt & Merrill Chapter VIII.

X. Conclusion

January 24: Overview of course. No reading.

All materials designed in Hutt & Merrill as "Notes" are optional reading.

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