Tag: pharmacovigilance

How the FDA Monitors Generic Drug Safety After Approval
How the FDA Monitors Generic Drug Safety After Approval

Learn how the FDA uses FAERS, the Sentinel Initiative, and factory inspections to ensure generic drugs remain safe and effective after they hit the market.

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How to Report Serious Adverse Events for Generic Drugs: A Guide for Providers
How to Report Serious Adverse Events for Generic Drugs: A Guide for Providers

Learn the exact procedures for reporting serious adverse events for generic drugs, including how to use MedWatch and identify manufacturers using NDC codes.

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Dechallenge and Rechallenge in Drug Side Effects: What These Tests Mean
Dechallenge and Rechallenge in Drug Side Effects: What These Tests Mean

Dechallenge and rechallenge are key clinical tools used to determine if a drug is causing side effects. Stopping the drug (dechallenge) and safely restarting it (rechallenge) can confirm causality-helping doctors make safer treatment decisions.

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