FDA guidance

Changes to an Approved Application: Biological Products: Human Blood and Blood Components…

FDA guidance · Final · issued Dec 1, 2014

Key facts

Title Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final Guidance
Status Final
Issue date Dec 1, 2014
Center Center for Biologics Evaluation and Research
Issuing office Center for Biologics Evaluation and Research
Communication type Guidance Document
Regulated product Biologics
Docket number FDA-1999-D-3528
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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