RAPS RAC-US : Regulatory Affairs Certification (RAC) US

RAC-US real exams

Exam Code: RAC-US

Exam Name: Regulatory Affairs Certification (RAC) US

Updated: Oct 10, 2026

Q & A: 100 Questions and Answers

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  • No. of questions: 100
  • Languages: English
  • Duration: 02 Hours
  • Exam Format: Multiple choice
  • Passing score: 70%

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RAPS RAC-US Exam Syllabus Topics:

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

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