What Does FDA Approval Actually Mean?
When a medication receives FDA approval, it means the FDA has reviewed the manufacturer’s application and evaluated evidence regarding the medication’s:
- Safety
- Effectiveness
- Quality
- Manufacturing
- Dosing
- Labeling
- Appropriate patient populations
- Known risks and potential benefits
FDA approval does not mean a medication is completely risk-free.
Every medication has potential side effects and risks.
Instead, FDA approval means the medication has gone through a formal regulatory review process designed to determine whether its benefits outweigh its known risks for its approved uses.
This is an important distinction when comparing an FDA-approved medication with an unapproved product.