FDA guidance

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for…

FDA guidance · Final · issued Nov 9, 2020

Key facts

Title Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry: Guidance for Industry
Status Final
Issue date Nov 9, 2020
Center Center for Drug Evaluation and Research
Issuing office Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research
Communication type Guidance Document
Regulated product Biologics, Drugs
Topics User Fees
Docket number FDA-2017-D-5913
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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