FDA approval.

U.S. authorization to market a drug for specific indications.

FDA approval means the United States Food and Drug Administration has authorized a drug to be marketed for specified medical uses, based on a review of evidence that it is effective for those uses and that its benefits outweigh its risks. Approval is specific rather than general: it covers a named product, at defined strengths, made by a defined manufacturing process, for particular indications and populations, and it comes with approved labelling that documents the known risks and contraindications. Several peptide-based drugs hold approvals, chiefly in the metabolic and endocrine areas, and their status carries with it manufacturing standards, ongoing safety surveillance, and a route for reporting problems. The distinctions worth keeping straight are numerous. Approval in one country does not imply approval elsewhere, since regulators reach independent decisions. Prescribing an approved drug for an unapproved purpose is off-label use, which is lawful for physicians but means the specific use was not the one evaluated. And a research-use-only compound is not an unapproved drug in a queue somewhere; in most cases no application has ever been filed. The misunderstanding worth correcting is reading not FDA-approved as a mere technicality. It usually means the studies that would support approval do not exist.