Which organization in the US is responsible for approving drugs for public market use?

• A. United States Pharmacopeia (USP)
• B. FDA
• C. World Health Organization
• D. International Controls

Answer: (B)

In the US, approving drugs for public market use is the responsibility of the Food and Drug Administration. The FDA reviews comprehensive data from laboratory and clinical studies to determine whether a drug is safe and effective for its intended use. After a sponsor submits a New Drug Application or Biologics License Application, the FDA assesses the evidence, inspects manufacturing facilities for quality, and evaluates labeling and safety monitoring plans. If the benefits outweigh the risks, the FDA approves the drug for sale under specified conditions and requires ongoing post-market surveillance. The United States Pharmacopeia, while it sets official quality standards for medicines, does not grant market approval. The World Health Organization provides international guidance, not country-specific drug approvals. “International Controls” is not a US regulatory body.