Tag: ANDA approval

FDA Safety Standards: How Generic Drugs Meet Brand Name Drug Requirements

FDA Safety Standards: How Generic Drugs Meet Brand Name Drug Requirements
Posted by: Lesley Williams in: Prescription Drugs
16 Nov | 04:04 AM

The FDA ensures generic drugs meet the same safety and effectiveness standards as brand-name drugs through strict bioequivalence testing, manufacturing oversight, and labeling rules. Generics are not cheaper because they're weaker-they're cheaper because they don't repeat expensive clinical trials.

FDA generic drug safety generic vs brand name drugs ANDA approval bioequivalence generic drug standards
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