FDA guidance
Assessing User Fees Under the Biosimilar User Fee Amendments of 2022: Guidance for…
FDA guidance · Final · issued Jul 31, 2023
Key facts
| Title | Assessing User Fees Under the Biosimilar User Fee Amendments of 2022: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Jul 31, 2023 |
| 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 | Drugs |
| Topics | User Fees |
| Docket number | FDA-2017-D-6209 |
| 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