Which agency is responsible for approving new medications for use in the United States?

Prepare for the PTCB Pharmacy Law Exam. Study with interactive quizzes featuring questions with hints and explanations. Get ready to ace your test!

The agency responsible for approving new medications for use in the United States is the Food and Drug Administration (FDA). The FDA plays a critical role in ensuring that medications are safe, effective, and manufactured according to quality standards before they can be sold to the public. This involves a rigorous review process of clinical trial data provided by pharmaceutical companies, plus assessment of the benefits and risks of new drugs.

The FDA's mission is to protect public health by overseeing the development and approval of drugs, biosimilars, and medical devices, ensuring that they meet the required standards for safety and efficacy. They also conduct post-marketing surveillance to monitor the drugs' performance in the general population after approval.

While other agencies like the Drug Enforcement Administration (DEA) regulates controlled substances, the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) focus on global health policies and public health, respectively, rather than the specific approval of medications for use within the United States.

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