Tag: generic drug approval
Manufacturing Changes and Generic Approval: What Triggers FDA Re-Evaluation
Manufacturing changes in generic drugs can trigger full FDA re-evaluation. Learn what modifications require prior approval, how long reviews take, and how new programs are speeding up the process.
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How Long Does the FDA Take to Approve Generic Drugs? 2025 Timelines Explained
Discover how long the FDA takes to approve generic drugs in 2025, from standard 10-month reviews to fast-tracked 1-2 month approvals for critical medications. Learn what affects approval time and why it matters for your health.
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