Tag: Hatch-Waxman Act

FDA Safety Alerts Explained: How Generic Drug Warnings Work

FDA Safety Alerts Explained: How Generic Drug Warnings Work

Jun, 13 2026

Learn how FDA safety alerts work for generic drugs, why labeling lags behind brand names, and what you can do to stay safe.

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Paragraph IV Certifications: How Generics Challenge Drug Patents

Paragraph IV Certifications: How Generics Challenge Drug Patents

May, 16 2026

Explore how Paragraph IV certifications allow generic drug makers to challenge brand-name patents under the Hatch-Waxman Act. Learn about the 180-day exclusivity, litigation risks, and strategic impacts on drug pricing.

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