FDA guidance

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program

FDA guidance · Draft · issued Nov 1, 2022

Key facts

Title Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
Status Draft
Issue date Nov 1, 2022
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 2021-709
Open for comment No
Document on fda.gov fda.gov

At a glance

  • None Product codes referenced
  • None Recognized standards referenced

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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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