Tag: generic drug approval
Deficiency Letters in Generic Drug Applications: Top FDA Findings and How to Avoid Them
FDA deficiency letters are the most common reason generic drug applications are delayed. Learn the top 5 findings, why they happen, and how to avoid them with proven strategies based on FDA data from 2023-2024.
How Bioequivalence Studies Are Conducted: Step-by-Step Process
Bioequivalence studies prove generic drugs work the same as brand-name ones by measuring how quickly and completely the body absorbs the active ingredient. Learn the step-by-step process behind these critical tests.
FDA Generic Drug Approval: Complete Step-by-Step Process
Learn the complete step-by-step process the FDA uses to approve generic drugs through the ANDA pathway. Understand bioequivalence, manufacturing standards, review timelines, and why generics are safe and affordable.