Redbook 2000: IV.C.9.a.Guidelines for Reproduction Studies

Description

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Scope & Applicability

Regulatory Context

• 21CFR170.3§ 170.3 Definitions.

  For the purposes of this subchapter, the following definitions apply: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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• Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
• Redbook 2000: IV.C.9.b. Guidelines for Developmental Toxicity Studies (Status: Final)