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Updated: Oct 18, 2026
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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Strategic Planning | 24% | - Risk management and quality systems - Product lifecycle strategy - US regulatory environment and framework - Regulatory pathways and marketing authorization |
| Topic 2: Post-Market and Compliance | 24% | - Inspections, audits, and enforcement actions - Reporting obligations and adverse events - Compliance and continuous improvement - Post-marketing surveillance and pharmacovigilance |
| Topic 3: Development and Pre-Market | 28% | - Design controls and technical documentation - Labeling and advertising regulations - CMC and manufacturing requirements - Clinical trials and non-clinical studies |
| Topic 4: Submissions and Regulatory Interactions | 24% | - eCTD and electronic submission formats - FDA review processes and communications - Regulatory intelligence and planning - Modifications, supplements, and variations |
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