FDA guidance

E6(R3) Good Clinical Practice: Annex 2

FDA guidance · Draft · issued Dec 30, 2024

Key facts

Title E6(R3) Good Clinical Practice: Annex 2
Status Draft
Issue date Dec 30, 2024
Center Center for Drug Evaluation and Research
Issuing office Center for Drug Evaluation and Research
Communication type Guidance Document
Regulated product Drugs
Docket number FDA-2024-D-5601
Comments close Feb 28, 2025
Open for comment No
Document on fda.gov fda.gov

At a glance

  • None Product codes referenced
  • None Recognized standards referenced

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About FDA guidance documents

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents

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