Tag: generic drug approval

Deficiency Letters in Generic Drug Applications: Common FDA Findings and How to Avoid Them
21 Mar

Deficiency Letters in Generic Drug Applications: Common FDA Findings and How to Avoid Them

Ashley Rioux

FDA deficiency letters are a major hurdle for generic drug makers. Learn the top 5 reasons applications get rejected - and how to avoid them with better preparation, documentation, and pre-submission strategies.

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Hatch-Waxman Act: How U.S. Law Made Generic Drugs Affordable and Accessible
27 Jan

Hatch-Waxman Act: How U.S. Law Made Generic Drugs Affordable and Accessible

Ashley Rioux

The Hatch-Waxman Act revolutionized U.S. drug access by creating a fast, affordable path for generic drugs. It saved $1.7 trillion and now powers over 90% of prescriptions.

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