United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2023_register executive 2023-09-21 article Notices D09002ee1c79929d6 D09002ee1c7992a8a United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies." This guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct and operations due to disasters or public health emergencies, which can include but are not limited to hurricanes, earthquakes, military conflicts, infectious disease outbreaks, or bioterrorist attacks. The appendix to this guidance further explains those approaches by providing answers to questions that the Agency has received about conducting clinical trials during major disruptions. 88 FR 65177 https://www.govinfo.gov/app/details/FR-2023-09-21/2023-20474 2023-20474 fr21se23-41 4164-01-P Docket No. FDA-2023-D-3550 https://www.govinfo.gov/app/details/FR-2023-09-21/2023-20474 https://www.govinfo.gov/content/pkg/FR-2023-09-21/html/2023-20474.htm https://www.govinfo.gov/content/pkg/FR-2023-09-21/pdf/2023-20474.pdf 3 p. 65177 65179 88 FR 65177 Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards; Availability; Federal Register Vol. 88, Issue NOTICE 2023-20474 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2023-D-3550 4164-01-P 2023-20474 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies." This guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct and operations due to disasters or public health emergencies, which can include but are not limited to hurricanes, earthquakes, military conflicts, infectious disease outbreaks, or bioterrorist attacks. The appendix to this guidance further explains those approaches by providing answers to questions that the Agency has received about conducting clinical trials during major disruptions.

The announcement of the guidance is published in the Federal Register on September 21, 2023. Dat Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 301 796-2500, CDEROMP@fda.hhs.gov; Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Soma Kalb, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-6359. Guidance: Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies, CDEROMP@fda.hhs.gov https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 88, no. 182 Office of the Federal Register, National Archives and Records Administration 2023-09-21 continuing daily deposited born digital 203 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2023-09-21 P0b002ee1c0ed438e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21se23 https://www.govinfo.gov/app/details/FR-2023-09-21 https://www.govinfo.gov/content/pkg/FR-2023-09-21/pdf/FR-2023-09-21.pdf https://www.govinfo.gov/content/pkg/FR-2023-09-21/xml/FR-2023-09-21.xml fdlp 65109 65304 DGPO 2023-09-21 2024-05-28 FR-2023-09-21 machine generated eng FR FR-2023-09-21 88 182