RAC-Drugs Exam (Summer 2025) questions with answers

RAC-Drugs Exam (Summer 2025) questions |\ |\ |\ |\ |\




with answers |\




Food & Drug Administration (FDA) - CORRECT ANSWERS
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✔✔Agency of Dept. of Health & Human Services (HHS). Protects
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public health by assuring safety, efficacy, and security of human
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drugs and biological products. Inspects imported goods. Works
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with foreign bodies and external agencies to ensure medicinal
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products are safe and secure for human use.
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Office of Regulatory Affairs (ORA) - CORRECT ANSWERS
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✔✔Inspects and reviews products offered for entry into US.
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Implement policies and outreaches for product portfolios.
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Office of Global Policy & Strategy (OGPS) - CORRECT ANSWERS
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✔✔serves as a pan-agency coordinator, information distributor,
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and access point for multilateral organizations. Addresses
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international trade of regulated products and mutual recognition
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agreements, facilitates information with global counterparts, and
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manages FDA's foreign offices. |\ |\ |\




Office of International Products (OIP) - CORRECT ANSWERS
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✔✔coordinates the FDA's international work to help foster |\ |\ |\ |\ |\ |\ |\ |\


partnerships with counterpart foreign agencies and international
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orgs. Offices focus on specific regions: Latin America (Costa
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Rica); Europe (Brussels, London); China (Beijing), and India (New
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Delhi).

, Confidentiality Commitment - CORRECT ANSWERS ✔✔sets up |\ |\ |\ |\ |\ |\ |\


legal framework for FDA to share certain kinds of non-public info
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with international orgs and regulators in other countries as part
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of cooperative law enforcement or regulatory activities.
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Cooperative Arrangements - CORRECT ANSWERS ✔✔written |\ |\ |\ |\ |\ |\


document that describes the good-faith intentions of the FDA,
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other regulators, and international orgs to engage in cooperative
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activities.


International Committee for Harmonisation of Technical |\ |\ |\ |\ |\ |\


Requirements for Pharmaceuticals for Human Use (ICH) - |\ |\ |\ |\ |\ |\ |\ |\


CORRECT ANSWERS ✔✔develops guidelines based on scientific
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discussions among regulatory authorities and the pharmaceutical |\ |\ |\ |\ |\ |\


industry. guidelines are updated continuously. Mission is to
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achieve greater harmonization worldwide and ensure that safe,
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effective, and high-quality medicines are developed, registered,
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and maintained in the most resource-efficient manner while
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meeting high standards. |\ |\




Office of Global Affairs (OGA) - CORRECT ANSWERS ✔✔Provides
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leadership and expertise in global health diplomacy to contribute
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to a safer, healthier world.
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European Medicines Agency (EMA) - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\


✔✔Protects and promotes human and animal health by |\ |\ |\ |\ |\ |\ |\ |\


evaluating and monitoring medicines with the EU. |\ |\ |\ |\ |\ |\