# Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/development-of-monoclonal-antibody-products-targeting-sars-cov-2-for-emergency-use-authorization/0146d188-0350-4f83-b103-4193b8be1e41

> FDA guidance document: Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization. Issue date: December 21, 2023. Get complete insights and analysis.

---

## Details

- Title: Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization
- 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: 2023-12-21
- Last Changed: 2023-12-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-1136">FDA-2020-D-1136</a>

## Related Documents

- [Reformulating Drug Products That Contain Carbomers Manufactured With Benzene](https://www.globalkeysolutions.net/guidances/guidance-document/reformulating-drug-products-that-contain-carbomers-manufactured-with-benzene/eca61c4a-9786-4068-b4e8-00d8444874c6)
- [Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities](https://www.globalkeysolutions.net/guidances/guidance-document/recommended-acceptable-intake-limits-for-nitrosamine-drug-substance-related-impurities/6238372e-b9bf-421b-9c22-eda707398371)
- [COVID-19: Developing Drugs and Biological Products for Treatment or Prevention:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/covid-19-developing-drugs-and-biological-products-for-treatment-or-prevention-guidance-for-industry/a6c3249b-9395-4d0b-96dd-986a992b4139)