Which entity oversees the Drug Approval Procedure in the United States?

Prepare for the Federal Pharmacy Law Exam. Access detailed questions with hints and explanations to boost your understanding and confidence. Get exam ready effectively!

The Food and Drug Administration (FDA) is the agency responsible for overseeing the Drug Approval Procedure in the United States. The FDA's role includes ensuring that new drugs are safe and effective before they can be marketed to the public. This agency conducts thorough evaluations of clinical trial data that pharmaceutical companies submit during the approval process, ensuring compliance with established regulatory standards.

The FDA reviews the manufacturing processes and labeling to ensure that drugs meet safety and efficacy criteria set forth in law, which protects public health. It plays a critical role not only in approving new medications but also in monitoring ongoing safety after drugs are released into the market.

In contrast, the Federal Trade Commission focuses on enforcing laws against misleading advertising and unfair business practices, while the Centers for Disease Control and Prevention operates primarily in public health promotion and disease control rather than drug approval. The National Institutes of Health is primarily involved in biomedical research and does not oversee drug approval processes. Thus, the FDA is the appropriate entity for this purpose.

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