Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment

Description

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Acute Radiation Syndrome:  Developing Drugs for Prevention and Treatment.”  The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation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.

Scope & Applicability

Regulatory Context

• 21CFR314.610§ 314.610 Approval based on evidence of effectiveness from studies in animals.

  (a) FDA may grant marketing approval for a new drug product for which safety has been established and for which the requirements of § 314.600 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the drug product is reasonably likely to Read full regulation →

• 21CFR601.91§ 601.91 Approval based on evidence of effectiveness from studies in animals.

  (a) FDA may grant marketing approval for a biological product for which safety has been established and for which the requirements of § 601.90 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the biological product is reasonably likRead full regulation →

• 21CFR314.600§ 314.600 Scope.

  This subpart applies to certain new drug products that have been studied for their safety and efficacy in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. This subpRead full regulation →

• 21CFR314.650§ 314.650 Termination of requirements.

  If FDA determines after approval under this subpart that the requirements established in §§ 314.610(b)(2) , 314.620 , and 314.630 are no longer necessary for the safe and effective use of a drug product, FDA will so notify the applicant. Ordinarily, for drug products approved under § 314.610 , theseRead full regulation →

• 21CFR601.90§ 601.90 Scope.

  This subpart applies to certain biological products that have been studied for their safety and efficacy in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. This suRead full regulation →

• 21CFR601.95§ 601.95 Termination of requirements.

  If FDA determines after approval under this subpart that the requirements established in §§ 601.91(b)(2) , 601.92 , and 601.93 are no longer necessary for the safe and effective use of a biological product, FDA will so notify the applicant. Ordinarily, for biological products approved under § 601.91Read full regulation →

• 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .

  The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →

• 21CFR312.23§ 312.23 IND content and format.

  (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  CCIC Huatongwei International Inspection Co., Ltd.

  2025-08-26

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  Jiangsu Kerbio Medical Technology Group Co.

  2025-08-26

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

  Mid-Link Testing Company, Ltd

  2024-09-11

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

  Sanitation & Environmental Technology Institute dba SDWH

  2024-09-11

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  Samm Solutions, Inc., d.b.a. BTS Research

  2023-10-31

• Bioresearch Monitoring Program

  Valley Biosystems

  2022-08-09

• Good Laboratory Practice (GLP)

  Toxikon Corporation/Labcorp Bedford LLC

  2022-02-22

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  University of Kentucky

  2020-05-05

• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

  Steiner Biotechnology, LLC

  2020-04-07

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