FDA guidance

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

FDA guidance · Draft · issued Oct 30, 2017

Key facts

Title Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry
Status Draft
Issue date Oct 30, 2017
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

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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