Tag: generic drug approval

Generic Drug Approval Standards: Safety, Quality, and Strength Requirements

Explore the rigorous FDA standards for generic drug approval, including bioequivalence testing, cGMP compliance, and the impact of the Hatch-Waxman Act on drug safety and affordability.

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30-Month Stay: How Patent Litigation Delays Generic Drug Approval

The 30-month stay under the Hatch-Waxman Act lets brand drug companies delay generic approval by triggering patent lawsuits. While designed to protect innovation, it's often used to extend monopolies, costing consumers billions annually.

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Stability Testing for Generics: FDA Requirements Explained

The FDA requires rigorous stability testing for generic drugs to ensure they remain safe, potent, and effective throughout their shelf life. Learn the exact requirements, common pitfalls, and how manufacturers meet these standards.

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