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What are Information amendments submitted for?

  1. Changes in contact information

  2. New toxicology, chemistry, or other technical information and study discontinuation

  3. Updates on patient recruitment numbers

  4. Annual financial disclosures

The correct answer is: New toxicology, chemistry, or other technical information and study discontinuation

Information amendments are submitted to provide new toxicology, chemistry, or other technical information and to report study discontinuation. Options A, C, and D are incorrect because they do not pertain to the purpose of information amendments. Option A is about changes in contact information, which can be requested through other types of submissions. Option C is about updates on patient recruitment numbers, which can be included in other types of regulatory updates. Option D is about annual financial disclosures, which are not typically included in information amendments.

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