RAC Cheat Sheet 2026

The 29 highest-yield RAC facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. What is the role of the European Medicines Agency (EMA)? → Evaluate medicines in the European Union
2. What is a key responsibility of regulatory affairs professionals? → Ensure regulatory compliance
3. Which of the following is a required basic element of informed consent for a clinical trial, as specified in 21 CFR 50.25? → A disclosure of appropriate alternative procedures or courses of treatment, if any.
4. Which internal department is most often engaged during regulatory planning? → Clinical and R&D teams
5. What is the primary goal of Phase 1 clinical trials? → Assess safety and dosing
6. Which document is required to begin clinical trials in the U.S.? → Investigational New Drug (IND)
7. Which of the following is the LEAST likely to be a core component of a global strategic regulatory plan? → Detailed employee vacation and travel schedules.
8. What does an NDA submission include? → Complete safety, efficacy, and manufacturing data
9. How can regulatory professionals manage global submissions effectively? → Customize dossiers per region
10. Which application pathway is used to market a generic drug in the U.S.? → ANDA
11. What is pharmacovigilance? → Monitoring drug safety after approval
12. What role does regulatory intelligence play in strategic planning? → Informs proactive decision-making
13. What is the purpose of Risk Evaluation and Mitigation Strategies (REMS)? → Ensure safe use of high-risk medications
14. Under 21 CFR 820.30, Design Controls are required for which of the following categories of medical devices? → All Class II, Class III, and certain specified Class I devices.
15. What is the role of a Common Technical Document (CTD)? → To harmonize regulatory submissions
16. Which of the following is part of post-market surveillance for medical devices? → Post-market surveillance and reporting
17. What is the purpose of the ICH guidelines? → International harmonization of drug regulations
18. Why is strategic planning important in regulatory affairs? → To align regulatory goals with company strategy
19. The central principle of a Premarket Notification (510(k)) submission is demonstrating: → Substantial equivalence to a predicate device
20. What is a Class I recall? → Potentially serious health risk
21. Which form is submitted to the FDA to report an adverse drug event? → Form FDA 3500
22. What is a key feature of effective regulatory communication? → Clear, accurate, and timely dialogue
23. Which post-market requirement ensures continued compliance with good manufacturing practices? → FDA inspections and audits
24. Which document outlines a company's regulatory submission strategy? → Regulatory strategy plan
25. Which regulatory document is used to gain permission to ship a drug across state lines before approval? → Investigational New Drug (IND)
26. Which phase of clinical trials focuses on therapeutic effectiveness? → Phase 2
27. In the context of Good Clinical Practice (GCP), which of the following is a primary responsibility of a clinical trial investigator? → Protecting the rights, safety, and well-being of trial subjects.
28. Which regulatory pathway expedites the review of drugs for serious conditions in the U.S.? → Fast Track designation
29. Which U.S. law established the FDA’s authority to oversee drug safety? → Food, Drug, and Cosmetic Act