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Form FDA 1571

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About the Author
Proxima CRO Team
Joel Reid
Regulatory Affairs Associate
Throughout his experience at Proxima, Joel has developed his skills to advise companies in the best path forward in the development of drugs and devices across a range of therapeutic and diagnostic areas.

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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