us-fda-guidance-343d9fd0c00d62b5259804163673de39•Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry
us-fda-guidance-343d9fd0c00d62b5259804163673de39Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for IndustryDraft Guidance
Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.
- Docket Number:
- FDA-2012-D-0880
- Issued by:
- Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2012-D-0880.
Continue your research in ChatGPT or Claude
Connect Omnilex to search the legal corpus from your AI assistant.