The FDA requires generic drug manufacturers to prove bioequivalence through strict pharmacokinetic studies, ensuring their products match the brand-name drug in absorption and effectiveness. This process ensures safety, efficacy, and cost savings for patients.
Secondary patents allow drug companies to extend market exclusivity beyond the original patent. Learn how these legal tools delay generic competition, impact drug prices, and spark industry debates.
The FDA now conducts unannounced inspections of foreign generic drug factories to ensure safety. With 90% of U.S. generics made overseas, stricter oversight is critical. Learn how CGMP standards, new inspection rules, and global reforms are changing drug safety in 2026.
Learn how the FDA uses therapeutic equivalence codes to determine which generic drugs can be safely substituted for brand-name medications. Understand AB and B codes, the Orange Book, and what this means for your prescriptions.
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