Tag: ANDA
Manufacturing Changes and Generic Approval: What Triggers FDA Re-evaluation
Learn what manufacturing changes trigger FDA re-evaluation for generic drugs, how the approval process works, and why delays happen - plus how new programs are speeding things up.
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Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible
The Hatch-Waxman Amendments of 1984 created the modern generic drug system in the U.S., allowing cheaper copies of brand-name drugs while protecting innovation. Today, 90% of prescriptions are filled with generics thanks to this law.
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