FDA guidance

Assessing User Fees Under the Generic Drug User Fee Amendments of 2022

FDA guidance · Final · issued Jun 9, 2023

Key facts

Title Assessing User Fees Under the Generic Drug User Fee Amendments of 2022
Status Final
Issue date Jun 9, 2023
Center Center for Drug Evaluation and Research
Issuing office Center for Drug Evaluation and Research
Communication type Guidance Document
Regulated product Drugs
Topics User Fees
Docket number FDA-2012-D-0880
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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