# Assessing User Fees Under the Biosimilar User Fee Amendments of 2022:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/assessing-user-fees-under-the-biosimilar-user-fee-amendments-of-2022-guidance-for-industry/4fbb7da7-e7da-4ffb-a835-53f0fa1a9dda

> FDA guidance document: Assessing User Fees Under the Biosimilar User Fee Amendments of 2022:  Guidance for Industry. Issue date: July 31, 2023. Get complete insights and analysis.

---

## Details

- Title: Assessing User Fees Under the Biosimilar User Fee Amendments of 2022:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-07-31
- Last Changed: 2023-07-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-6209">FDA-2017-D-6209</a>

## Related Documents

- [Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/limited-population-pathway-for-antibacterial-and-antifungal-drugs-guidance-for-industry/f01d33af-ed26-4eb5-961a-03e00c90f2c7)
- [Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022](https://www.globalkeysolutions.net/guidances/guidance-document/assessing-user-fees-under-the-prescription-drug-user-fee-amendments-of-2022/a1bfde05-8672-4537-9ef7-bdf6377a9f3b)
- [Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/assessing-user-fees-under-the-prescription-drug-user-fee-amendments-of-2017-guidance-for-industry-guidance-for-industry/0a6a0a53-093e-48c0-a832-4e3db4e95cd6)