Form FDA 1571

The Form FDA 1571 is used to obtain agreement from a sponsor or sponsor-investigator to conduct research in adherence to all appropriate FDA regulations. It also serves as a cover sheet and is completed for every submission sent to the FDA on behalf of a specific IND. You should include the following information on the 1571:

• Contact information and mailing address of the Sponsor (or Sponsor Investigator)
• IND number, if it has been issued
• Serial number  
• The name(s) of the drug/biologic and the indication being studied
• The contents of the submission
• Name and title of the individuals responsible for monitoring the study and reviewing safety data

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