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What is an exception for the content of an IND for studies of marketed products compared to new drugs?

  1. A detailed budget breakdown

  2. A copy of the approved labeling can be provided in lieu of the Investigator's Brochure

  3. A new clinical trial protocol summary

  4. Detailed clinical study results

The correct answer is: A copy of the approved labeling can be provided in lieu of the Investigator's Brochure

An exception for the content of an IND for studies of marketed products compared to new drugs is that a copy of the approved labeling can be provided in lieu of the Investigator's Brochure. This is because the approved labeling for a marketed product already contains detailed information on the safety and efficacy of the drug, making an additional Investigator's Brochure unnecessary. The other options, a detailed budget breakdown, a new clinical trial protocol summary, and detailed clinical study results, are not exceptions for the content of an IND and would typically not be included in an IND submission for either new drugs or marketed products.

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