RAC-Drugs Exam (Summer 2025) questions |\ |\ |\ |\ |\
with answers |\
Food & Drug Administration (FDA) - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\
✔✔Agency of Dept. of Health & Human Services (HHS). Protects
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
public health by assuring safety, efficacy, and security of human
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
drugs and biological products. Inspects imported goods. Works
|\ |\ |\ |\ |\ |\ |\ |\
with foreign bodies and external agencies to ensure medicinal
|\ |\ |\ |\ |\ |\ |\ |\ |\
products are safe and secure for human use.
|\ |\ |\ |\ |\ |\ |\
Office of Regulatory Affairs (ORA) - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\
✔✔Inspects and reviews products offered for entry into US.
|\ |\ |\ |\ |\ |\ |\ |\ |\
Implement policies and outreaches for product portfolios.
|\ |\ |\ |\ |\ |\
Office of Global Policy & Strategy (OGPS) - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔serves as a pan-agency coordinator, information distributor,
|\ |\ |\ |\ |\ |\ |\
and access point for multilateral organizations. Addresses
|\ |\ |\ |\ |\ |\ |\
international trade of regulated products and mutual recognition
|\ |\ |\ |\ |\ |\ |\ |\
agreements, facilitates information with global counterparts, and
|\ |\ |\ |\ |\ |\ |\
manages FDA's foreign offices. |\ |\ |\
Office of International Products (OIP) - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\
✔✔coordinates the FDA's international work to help foster |\ |\ |\ |\ |\ |\ |\ |\
partnerships with counterpart foreign agencies and international
|\ |\ |\ |\ |\ |\ |\
orgs. Offices focus on specific regions: Latin America (Costa
|\ |\ |\ |\ |\ |\ |\ |\ |\
Rica); Europe (Brussels, London); China (Beijing), and India (New
|\ |\ |\ |\ |\ |\ |\ |\ |\
Delhi).
, Confidentiality Commitment - CORRECT ANSWERS ✔✔sets up |\ |\ |\ |\ |\ |\ |\
legal framework for FDA to share certain kinds of non-public info
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\
with international orgs and regulators in other countries as part
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
of cooperative law enforcement or regulatory activities.
|\ |\ |\ |\ |\ |\
Cooperative Arrangements - CORRECT ANSWERS ✔✔written |\ |\ |\ |\ |\ |\
document that describes the good-faith intentions of the FDA,
|\ |\ |\ |\ |\ |\ |\ |\ |\
other regulators, and international orgs to engage in cooperative
|\ |\ |\ |\ |\ |\ |\ |\ |\
activities.
International Committee for Harmonisation of Technical |\ |\ |\ |\ |\ |\
Requirements for Pharmaceuticals for Human Use (ICH) - |\ |\ |\ |\ |\ |\ |\ |\
CORRECT ANSWERS ✔✔develops guidelines based on scientific
|\ |\ |\ |\ |\ |\ |\
discussions among regulatory authorities and the pharmaceutical |\ |\ |\ |\ |\ |\
industry. guidelines are updated continuously. Mission is to
|\ |\ |\ |\ |\ |\ |\ |\ |\
achieve greater harmonization worldwide and ensure that safe,
|\ |\ |\ |\ |\ |\ |\ |\
effective, and high-quality medicines are developed, registered,
|\ |\ |\ |\ |\ |\ |\
and maintained in the most resource-efficient manner while
|\ |\ |\ |\ |\ |\ |\ |\
meeting high standards. |\ |\
Office of Global Affairs (OGA) - CORRECT ANSWERS ✔✔Provides
|\ |\ |\ |\ |\ |\ |\ |\ |\
leadership and expertise in global health diplomacy to contribute
|\ |\ |\ |\ |\ |\ |\ |\ |\
to a safer, healthier world.
|\ |\ |\ |\
European Medicines Agency (EMA) - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\
✔✔Protects and promotes human and animal health by |\ |\ |\ |\ |\ |\ |\ |\
evaluating and monitoring medicines with the EU. |\ |\ |\ |\ |\ |\
with answers |\
Food & Drug Administration (FDA) - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\
✔✔Agency of Dept. of Health & Human Services (HHS). Protects
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
public health by assuring safety, efficacy, and security of human
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
drugs and biological products. Inspects imported goods. Works
|\ |\ |\ |\ |\ |\ |\ |\
with foreign bodies and external agencies to ensure medicinal
|\ |\ |\ |\ |\ |\ |\ |\ |\
products are safe and secure for human use.
|\ |\ |\ |\ |\ |\ |\
Office of Regulatory Affairs (ORA) - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\
✔✔Inspects and reviews products offered for entry into US.
|\ |\ |\ |\ |\ |\ |\ |\ |\
Implement policies and outreaches for product portfolios.
|\ |\ |\ |\ |\ |\
Office of Global Policy & Strategy (OGPS) - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
✔✔serves as a pan-agency coordinator, information distributor,
|\ |\ |\ |\ |\ |\ |\
and access point for multilateral organizations. Addresses
|\ |\ |\ |\ |\ |\ |\
international trade of regulated products and mutual recognition
|\ |\ |\ |\ |\ |\ |\ |\
agreements, facilitates information with global counterparts, and
|\ |\ |\ |\ |\ |\ |\
manages FDA's foreign offices. |\ |\ |\
Office of International Products (OIP) - CORRECT ANSWERS
|\ |\ |\ |\ |\ |\ |\ |\
✔✔coordinates the FDA's international work to help foster |\ |\ |\ |\ |\ |\ |\ |\
partnerships with counterpart foreign agencies and international
|\ |\ |\ |\ |\ |\ |\
orgs. Offices focus on specific regions: Latin America (Costa
|\ |\ |\ |\ |\ |\ |\ |\ |\
Rica); Europe (Brussels, London); China (Beijing), and India (New
|\ |\ |\ |\ |\ |\ |\ |\ |\
Delhi).
, Confidentiality Commitment - CORRECT ANSWERS ✔✔sets up |\ |\ |\ |\ |\ |\ |\
legal framework for FDA to share certain kinds of non-public info
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\
with international orgs and regulators in other countries as part
|\ |\ |\ |\ |\ |\ |\ |\ |\ |\
of cooperative law enforcement or regulatory activities.
|\ |\ |\ |\ |\ |\
Cooperative Arrangements - CORRECT ANSWERS ✔✔written |\ |\ |\ |\ |\ |\
document that describes the good-faith intentions of the FDA,
|\ |\ |\ |\ |\ |\ |\ |\ |\
other regulators, and international orgs to engage in cooperative
|\ |\ |\ |\ |\ |\ |\ |\ |\
activities.
International Committee for Harmonisation of Technical |\ |\ |\ |\ |\ |\
Requirements for Pharmaceuticals for Human Use (ICH) - |\ |\ |\ |\ |\ |\ |\ |\
CORRECT ANSWERS ✔✔develops guidelines based on scientific
|\ |\ |\ |\ |\ |\ |\
discussions among regulatory authorities and the pharmaceutical |\ |\ |\ |\ |\ |\
industry. guidelines are updated continuously. Mission is to
|\ |\ |\ |\ |\ |\ |\ |\ |\
achieve greater harmonization worldwide and ensure that safe,
|\ |\ |\ |\ |\ |\ |\ |\
effective, and high-quality medicines are developed, registered,
|\ |\ |\ |\ |\ |\ |\
and maintained in the most resource-efficient manner while
|\ |\ |\ |\ |\ |\ |\ |\
meeting high standards. |\ |\
Office of Global Affairs (OGA) - CORRECT ANSWERS ✔✔Provides
|\ |\ |\ |\ |\ |\ |\ |\ |\
leadership and expertise in global health diplomacy to contribute
|\ |\ |\ |\ |\ |\ |\ |\ |\
to a safer, healthier world.
|\ |\ |\ |\
European Medicines Agency (EMA) - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\
✔✔Protects and promotes human and animal health by |\ |\ |\ |\ |\ |\ |\ |\
evaluating and monitoring medicines with the EU. |\ |\ |\ |\ |\ |\
