Tag: ANDA approval

Bioequivalence Studies: What the FDA Requires Manufacturers to Prove

Bioequivalence Studies: What the FDA Requires Manufacturers to Prove

The FDA requires generic drug manufacturers to prove bioequivalence through rigorous clinical studies that show their product matches the brand-name drug in absorption and blood concentration. This ensures safety, effectiveness, and therapeutic equivalence.

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Generic Drug Quality Standards: FDA Requirements and Testing

Generic Drug Quality Standards: FDA Requirements and Testing

Generic drugs must meet the same strict FDA standards as brand-name drugs, including pharmaceutical and bioequivalence. Learn how the FDA ensures quality, safety, and effectiveness through rigorous testing, inspections, and approval processes.

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