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Who approves the medications on the market (OTC & SCRIPTS)?

1 Answer

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Final answer:

The FDA approves both OTC and prescription medications in the U.S., ensuring their safety and efficacy before they can be sold, with advertising for these drugs also regulated by the FDA and the FTC.

Step-by-step explanation:

The organization responsible for approving medications, both over-the-counter (OTC) and prescription drugs, in the United States is the Food and Drug Administration (FDA). The FDA's Center for Drug Evaluation and Research (CDER) manages the regulatory process for these medications. Prescription drugs are subject to extensive review through a New Drug Application (NDA) before they can be marketed. OTC drugs, meanwhile, are regulated by the FDA and typically comprise ingredients that were once prescription medications but have since been found safe enough for use without a doctor's supervision. Advertising and promotion for prescription drugs are monitored by the FDA's Office of Prescription Drug Promotion, whereas the Federal Trade Commission regulates advertising for OTC drugs.

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