# Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/assessing-user-fees-under-the-over-the-counter-monograph-drug-user-fee-program/cd0a751e-3682-43b3-b40d-fb7c5e1da162

> FDA guidance document: Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program. Issue date: November 01, 2022. Get complete insights and analysis.

---

## Details

- Title: Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
- 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: 2022-11-01
- Last Changed: 2022-11-01
- Docket Number: <a href="https://www.regulations.gov/docket/2021-709">2021-709</a>

## Related Documents

- [Requests for Reconsideration at the Division Level Under GDUFA](https://www.globalkeysolutions.net/guidances/guidance-document/requests-for-reconsideration-at-the-division-level-under-gdufa/57f559b5-e6c3-492b-91fd-01762f90e676)
- [Competitive Generic Therapies](https://www.globalkeysolutions.net/guidances/guidance-document/competitive-generic-therapies/402bfb2a-4126-427d-9a19-4507e22c6b0e)
- [Assessing User Fees Under the Generic Drug User Fee Amendments of 2022](https://www.globalkeysolutions.net/guidances/guidance-document/assessing-user-fees-under-the-generic-drug-user-fee-amendments-of-2022/f97fbaf6-3c85-4cbc-ac92-15d0649f8092)