This question is about us pharmaceutical statistics.

Which organizations can approve new drugs in the U.S.?

By Zippia Team - Dec. 7, 2022

The only organization that can approve new drugs in the U.S. is the U.S. Food and Drug Administration (FDA).

The FDA has different processes for over-the-counter (OTC) and prescription drugs. For OTC medications, the FDA approves active ingredients and provides parameters for certain types of drugs but doesn't do any studies beyond that. Some OTCs don't even need FDA approval.

On the other hand, prescription medications do need to be thoroughly tested and approved by the FDA before they can hit the market.

Which organizations can approve new drugs in the U.S.?

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