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FDA Drug Study Phases and Post-Approval Data Collection

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SebastianRzuHarrisw

The FDA may request additional data after a New Drug Application is submitted. A Sponsor can receive conditional approval to market a drug requiring a Phase 4 trial to collect more information. Safety and side effect data is collected in all clinical trials.

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After the Sponsor submits the New Drug Application, the FDA may request that additional data be collected. The Sponsor may receive conditional approval with the requirement to conduct a Phase 4 trial to collect additional information. IV II III Question 10 ( 2 points) Identify the drug study phase: Safety and side effect data is not collected. III II IV None of the above. This data is collected in all clinical trials.

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FDA Drug Study Phases and Post-Approval Data Collection

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