RAC Regulatory Frameworks

Question 1

Which U.S. law established the FDA’s authority to oversee drug safety?

Accepted Answer

Food, Drug, and Cosmetic Act

Answer

Kefauver-Harris Amendment

Answer

Drug Listing Act

Answer

Prescription Drug Marketing Act

Question 2

What is the purpose of the ICH guidelines?

Accepted Answer

International harmonization of drug regulations

Answer

Local drug pricing regulation

Answer

Standardize preclinical animal testing only

Answer

Healthcare facility inspections

Question 3

What is a key responsibility of regulatory affairs professionals?

Accepted Answer

Ensure regulatory compliance

Answer

Oversee daily operations

Answer

Develop clinical trial protocols

Answer

Manage hospital workflows

Question 4

Which document is required to begin clinical trials in the U.S.?

Accepted Answer

Investigational New Drug (IND)

Answer

New Drug Application (NDA)

Answer

Biologics License Application (BLA)

Answer

Medical Device Reporting (MDR)

Question 5

What is the role of the European Medicines Agency (EMA)?

Accepted Answer

Evaluate medicines in the European Union

Answer

Approve U.S. drugs

Answer

Oversee food labeling

Answer

Manage health insurance claims

Question 6

Which regulatory pathway expedites the review of drugs for serious conditions in the U.S.?

Accepted Answer

Fast Track designation

Answer

ANDA

Answer

Orphan Drug Act

Answer

Hatch-Waxman Act