FDA approval 2 articles

FDA approval is the U.S. regulatory authorization that permits a drug or biologic to be marketed for specified indications under approved labeling after the agency reviews evidence of quality, safety and effectiveness. Approval can arise through different application and review pathways, and it may include postmarketing requirements or commitments. The term is distinct from designations such as breakthrough therapy or orphan drug status, which can support development but do not themselves authorize commercial marketing.