How are generic drugs approved by the Food and Drug Administration (FDA)?

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Marc B. Garnick, MD
Hematology & Oncology
To meet Food and Drug Administration (FDA) approval, a generic drug must be identical -- or bioequivalent -- to a brand-name drug in dosage, strength, safety, quality, how it works, how it's taken, and how it should be used. It must contain the same active ingredients as the brand-name drug, but inactive ingredients may vary.

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Drug Safety

Drug Safety

Prescription and OTC drugs marketed in the United States go through a review and testing process by the Food and Drug Administration (FDA). Dosage, side effects, manufacturing and safety are evaluated through this process. Familia...

rize yourself with drug warnings, drug label changes and any drug shortages, so you can protect and maintain your health.
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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.