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Guidance Documents/Information Sheet

Information Sheet Documents

Browse 17 information sheet documents from FDA and regulatory agencies.

Information Sheet Documents

17 documents available

5 shown

Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators

Information Sheet
February 5, 2025
🏢Office of the Commissioner,Office of the Chief Medical Officer,Office of Clinical Policy
Biologics, Drugs, Medical Devices
Original Document
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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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Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators

Information Sheet
January 29, 2018
🏢Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
Biologics, Drugs, Medical Devices
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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Document Statistics
Total Documents17
Document TypeInformation Sheet
Showing5 of 17
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