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 2023-04-20 article Notices D09002ee1c79d0fca D09002ee1c79d1057 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment." The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule. 88 FR 24427 https://www.govinfo.gov/app/details/FR-2023-04-20/2023-08331 2023-08331 fr20ap23-51 4164-01-P Docket No. FDA-2023-D-1146 https://www.govinfo.gov/app/details/FR-2023-04-20/2023-08331 https://www.govinfo.gov/content/pkg/FR-2023-04-20/html/2023-08331.htm https://www.govinfo.gov/content/pkg/FR-2023-04-20/pdf/2023-08331.pdf 3 p. 24427 24429 88 FR 24427 Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Availability; Federal Register Vol. 88, Issue NOTICE 2023-08331 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2023-07-19 Docket No. FDA-2023-D-1146 4164-01-P 2023-08331 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment." The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule.

Submit either electronic or written comments on the draft guidance by July 19, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Ronald Honchel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5426, Silver Spring, MD 20993, 301-796- 0915. Guidance: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 88, no. 76 Office of the Federal Register, National Archives and Records Administration 2023-04-20 continuing daily deposited born digital 153 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2023-04-20 P0b002ee1bd911147 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20ap23 https://www.govinfo.gov/app/details/FR-2023-04-20 https://www.govinfo.gov/content/pkg/FR-2023-04-20/pdf/FR-2023-04-20.pdf https://www.govinfo.gov/content/pkg/FR-2023-04-20/xml/FR-2023-04-20.xml fdlp 24327 24469 DGPO 2023-04-20 2024-05-29 FR-2023-04-20 machine generated eng FR FR-2023-04-20 88 76