Tag: ANDA approval
Tentative Approval for Generics: Common Reasons for Delays
- By : Tamsin Riverton
- Date : Dec 21 2025
Tentative approval from the FDA means a generic drug is scientifically ready - but not yet legal to sell. Common delays include patent lawsuits, manufacturing issues, and market economics that prevent launch even after approval.
Deficiency Letters in Generic Drug Applications: Common FDA Findings and How to Avoid Them
- By : Tamsin Riverton
- Date : Dec 17 2025
Deficiency letters from the FDA are the most common reason generic drug applications are delayed. Learn the top 5 findings-dissolution issues, impurity controls, sameness problems-and how to avoid them to speed up approval.
