Tag: ANDA process

Dissolution Testing: How the FDA Ensures Generic Drug Quality
Dissolution Testing: How the FDA Ensures Generic Drug Quality

Discover how the FDA uses dissolution testing and bioequivalence standards to ensure generic drugs work exactly like brand-name versions, preventing risks like dose-dumping.

Apr 30 2026

FDA Regulatory Authority: How the Agency Approves Generic Drugs
FDA Regulatory Authority: How the Agency Approves Generic Drugs

The FDA ensures generic drugs are safe and effective through the ANDA process, requiring bioequivalence to brand-name drugs without repeating clinical trials. Generics make up 90% of U.S. prescriptions and save billions annually.

Jan 15 2026