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| Section | Objectives |
|---|---|
| Topic 1: Premarket Requirements | - Labeling and promotional compliance - Marketing authorization pathways (NDA, ANDA, PMA, 510(k)) |
| Topic 2: Regulatory Foundations | - Regulatory ethics and compliance principles - US regulatory structure and agencies (FDA overview) |
| Topic 3: Postmarket Compliance | - Pharmacovigilance and adverse event reporting - Device vigilance and recalls |
| Topic 4: Product Development Lifecycle | - Drug and device development stages - Clinical trial frameworks and submissions (IND/IDE) |
| Topic 5: Quality Systems and Regulatory Operations | - GxP systems (GMP, GCP, GLP) - Inspections and regulatory audits |
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