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Regulatory Approval

Meaning

Regulatory approval is the formal, legally mandated authorization granted by a national or international government agency, such as the FDA or EMA, that permits a pharmaceutical product, medical device, or biological therapy to be marketed and sold for a specific clinical indication. This approval signifies that the agency has reviewed comprehensive scientific data and determined that the product is both safe and effective for its intended use, with benefits outweighing the known risks. Achieving regulatory approval is the final and most critical milestone in the clinical development process for any new hormonal or therapeutic intervention. This process ensures patient safety and product quality.