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What must be filed before conducting human clinical trials with an experimental drug?

  1. NDA submission

  2. Annual progress report

  3. IND application (Form FDA 1571)

  4. Safety updates

The correct answer is: IND application (Form FDA 1571)

Before conducting human clinical trials with an experimental drug, an IND application (Form FDA 1571) must be filed. This application requests permission from the FDA to conduct the clinical trials and contains information on the drug's chemistry, manufacturing, and controls; animal study data; and proposed clinical trial protocol. Option A, NDA submission, is incorrect because a New Drug Application (NDA) is filed after the clinical trials have been completed and the drug has been proven to be safe and effective. Option B, Annual progress report, is incorrect because an annual progress report is typically filed after an IND has been approved and clinical trials are already underway. Option D, Safety updates, is incorrect because safety updates are required throughout the clinical trial process but are not the initial filing required before conducting human clinical trials.

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