Massachusetts FDA Compliance Training Exam
question with correct answers (100% verified
answers) plus rationales Q &A
2026 INSTANT DOWNLOAD PDF
1. What is the primary role of the FDA?
A. Tax collection
B. Regulating food, drugs, and medical devices
C. Law enforcement
D. Insurance regulation
Answer: B
The FDA ensures safety and effectiveness of food, drugs, biologics, and medical
devices.
2. Which law governs drug safety in the U.S.?
A. HIPAA
B. FDCA
C. OSHA Act
D. CLIA
Answer: B
The Federal Food, Drug, and Cosmetic Act regulates drug safety and approval.
3. What does GMP stand for?
,A. General Medical Procedures
B. Good Manufacturing Practices
C. Global Medical Policy
D. General Manufacturing Protocol
Answer: B
GMP ensures products are consistently produced and controlled.
4. Which agency enforces FDA regulations?
A. CDC
B. DEA
C. FDA
D. WHO
Answer: C
The FDA enforces compliance through inspections and regulation.
5. What is required before a new drug is marketed?
A. Clinical trial approval
B. FDA approval
C. Insurance approval
D. Hospital approval
Answer: B
Drugs must be FDA-approved before public marketing.
6. What does IND stand for?
A. International New Drug
B. Investigational New Drug
C. Internal New Data
D. Industrial New Device
, Answer: B
IND allows clinical testing of new drugs.
7. Phase I trials primarily test:
A. Effectiveness
B. Marketing
C. Safety
D. Pricing
Answer: C
Phase I focuses on safety in humans.
8. Phase II trials focus on:
A. Safety only
B. Effectiveness
C. Advertising
D. Packaging
Answer: B
Phase II evaluates drug effectiveness.
9. Phase III trials involve:
A. Animals only
B. Large population testing
C. Marketing
D. Import/export
Answer: B
Phase III confirms safety and efficacy in large groups.
10. What does NDA stand for?
question with correct answers (100% verified
answers) plus rationales Q &A
2026 INSTANT DOWNLOAD PDF
1. What is the primary role of the FDA?
A. Tax collection
B. Regulating food, drugs, and medical devices
C. Law enforcement
D. Insurance regulation
Answer: B
The FDA ensures safety and effectiveness of food, drugs, biologics, and medical
devices.
2. Which law governs drug safety in the U.S.?
A. HIPAA
B. FDCA
C. OSHA Act
D. CLIA
Answer: B
The Federal Food, Drug, and Cosmetic Act regulates drug safety and approval.
3. What does GMP stand for?
,A. General Medical Procedures
B. Good Manufacturing Practices
C. Global Medical Policy
D. General Manufacturing Protocol
Answer: B
GMP ensures products are consistently produced and controlled.
4. Which agency enforces FDA regulations?
A. CDC
B. DEA
C. FDA
D. WHO
Answer: C
The FDA enforces compliance through inspections and regulation.
5. What is required before a new drug is marketed?
A. Clinical trial approval
B. FDA approval
C. Insurance approval
D. Hospital approval
Answer: B
Drugs must be FDA-approved before public marketing.
6. What does IND stand for?
A. International New Drug
B. Investigational New Drug
C. Internal New Data
D. Industrial New Device
, Answer: B
IND allows clinical testing of new drugs.
7. Phase I trials primarily test:
A. Effectiveness
B. Marketing
C. Safety
D. Pricing
Answer: C
Phase I focuses on safety in humans.
8. Phase II trials focus on:
A. Safety only
B. Effectiveness
C. Advertising
D. Packaging
Answer: B
Phase II evaluates drug effectiveness.
9. Phase III trials involve:
A. Animals only
B. Large population testing
C. Marketing
D. Import/export
Answer: B
Phase III confirms safety and efficacy in large groups.
10. What does NDA stand for?
