Information Sheet Documents

Browse 7 information sheet documents from FDA and regulatory agencies.

7 documents available

5 shown

Evaluation of Sex Differences in Clinical Investigations: Guidance for Industry

Information Sheet

January 20, 2025

🏢Office of the Commissioner

biologics

Original Document

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Waiver of IRB Requirements for Drug and Biological Product Studies: Guidance For Sponsors, Clinical Investigators, and IRBs

Information Sheet

October 3, 2017

🏢Office of the Commissioner

biologics

Original Document

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Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs

Information Sheet

June 4, 2010

🏢Office of the Commissioner

biologics

Original Document

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FDA Inspections of Clinical Investigators: Guidance For IRBs, Clinical Investigators, and Sponsors

Information Sheet

June 1, 2010

🏢Office of the Commissioner

devices

Original Document

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Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors

Information Sheet

January 1, 2006

🏢Office of the Commissioner

devices

Original Document

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Total Documents7

Document TypeInformation Sheet

Showing5 of 7

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