How to Ensure Your Generic Drug Meets FDA Standards

The FDA’s Office of Generic Drugs (OGD) follows a stringent review process to ensure generic drugs, which are typically 80-85% cheaper than brand-name drugs, meet the same quality standards. In order to meet FDA standards, a generic drug must demonstrate its pharmaceutical equivalence, bioequivalence, follow a similar manufacturing process, and ensure similar labelling, quality, and stability as the brand-name drugs. The review process ensures safe, effective, and affordable treatment options for patients.