Category: Prescription Medication Information
Bioequivalence Studies: What the FDA Requires Generic Drug Manufacturers to Prove
The FDA requires generic drug makers to prove their products match brand-name drugs in how the body absorbs them. Bioequivalence studies ensure safety, effectiveness, and cost savings for millions of patients.
How to Check REMS Requirements Before Starting a Medication
Learn how to check REMS requirements before starting a high-risk medication. Understand FDA-mandated safety steps, common requirements like prescriber certification, and how to avoid delays or serious health risks.