# Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/potency-assay-considerations-for-monoclonal-antibodies-and-other-therapeutic-proteins-targeting-viral-pathogens/1953041c-b51e-461d-b446-46cb6faf0d86

> FDA guidance document: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens. Issue date: March 01, 2023. Get complete insights and analysis.

---

## Details

- Title: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
- 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: 2023-03-01
- Comment Close Date: 2023-05-01
- Last Changed: 2023-03-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-0202">FDA-2023-D-0202</a>

## Related Documents

- [Clinical Pharmacology Considerations for Peptide Drug Products](https://www.globalkeysolutions.net/guidances/guidance-document/clinical-pharmacology-considerations-for-peptide-drug-products/1609c8ed-4d50-4235-8a00-9c63176affe8)
- [Psychedelic Drugs: Considerations for Clinical Investigations](https://www.globalkeysolutions.net/guidances/guidance-document/psychedelic-drugs-considerations-for-clinical-investigations/c22c8005-efa9-4373-893d-cf27911562b6)
- [Benefit-Risk Considerations for Product Quality Assessments](https://www.globalkeysolutions.net/guidances/guidance-document/benefit-risk-considerations-for-product-quality-assessments/dd4547d7-4ac9-437a-8d9b-b88b234da4bc)