FDA guidance

Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products…

FDA guidance · Final · issued Jan 24, 2006

Key facts

Title Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format
Status Final
Issue date Jan 24, 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 Drugs
Docket number FDA-2005-D-0153
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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