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# Draft Guidance on FDA-1572 Questions, Answers
- URL: https://www.fdaweb.com/draft-guidance-on-fda-1572-questions-answers/
- Published: 2021-05-20T12:00:00.000Z
- Updated: 2026-09-14T16:59:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149363

FDA has published a draft guidance, *Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions Statement of Investigator (Form FDA-1572) (Revision 1)*, describing how to complete FDA-1572 for clinical investigations conducted under IND regulations. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-sheet-guidance-sponsors-clinical-investigators-and-irbs-frequently-asked-questions?ref=fdaweb.com) partially revises a 5/2010 FDA-1572 FAQ (frequently asked questions) guidance and answers additional questions received by the agency.

The draft says the guidance has been developed in response to multiple inquiries about waivers of the signature requirement on FDA-1572 and when finalized will explain FDA’s current thinking about signature waivers.