What Are Food and Drug Administration (FDA) Approvals?

Food and Drug Administration (FDA) approvals refer to the rigorous process the FDA uses to evaluate the safety and effectiveness of drugs, medical devices, and other healthcare products before they can be sold in the U.S. The approval process ensures that treatments meet strict scientific standards and provide clinical benefits that outweigh potential risks.

How does the FDA approval process work?

• Preclinical Testing: Laboratory and animal studies assess initial safety and effectiveness.
• Clinical Trials: A multi-phase process involving human participants to test dosage, side effects, and overall impact.
• FDA Review & Decision: Experts analyze data before granting approval for public use.

Why does FDA approval matter?

• Ensures safety and efficacy: Prevents unproven or harmful treatments from reaching patients.
• Regulates prescription and over-the-counter drugs: Protects consumers from misleading health claims.
• Impacts Medicare and insurance coverage: Most insurers, including Medicare, only cover FDA-approved treatments.

How Solace can help

A Solace advocate can help you understand whether a treatment is FDA-approved, clarify insurance coverage for new medications, and assist with appeals if a prescribed treatment is denied. If you're considering an experimental drug or clinical trial, an advocate can also help you explore options and communicate with your healthcare team.

What to do next

Curious about FDA-approved treatments or insurance coverage? Find a Solace advocate today.