FDA guidance

S8 Immunotoxicity Studies for Human Pharmaceuticals

FDA guidance · Final · issued Apr 12, 2006

Key facts

Title S8 Immunotoxicity Studies for Human Pharmaceuticals
Status Final
Issue date Apr 12, 2006
Center Center for Drug Evaluation and Research
Issuing office Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
Communication type Guidance Document
Regulated product Biologics, Drugs
Docket number FDA-2005-D-0398
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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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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