# Benefit-Risk Assessment for New Drug and Biological Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/benefit-risk-assessment-for-new-drug-and-biological-products/90bf84f4-05cf-4617-b13d-bbb345349aed

> FDA guidance document: Benefit-Risk Assessment for New Drug and Biological Products. Issue date: October 17, 2023. Get complete insights and analysis.

---

## Details

- Title: Benefit-Risk Assessment for New Drug and Biological Products
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-10-17
- Last Changed: 2024-08-10
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-2316">FDA-2020-D-2316</a>

## Related Documents

- [Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/drug-drug-interaction-assessment-for-therapeutic-proteins-guidance-for-industry-guidance-for-industry/2a0a5163-7a5f-4b3c-9eef-d94d670b6733)
- [Identification of Medicinal Products —  Implementation and Use](https://www.globalkeysolutions.net/guidances/guidance-document/identification-of-medicinal-products-implementation-and-use/389d6672-9c7a-4d0b-8c2f-dfd968df1f09)
- [Q13 Continuous Manufacturing of Drug Substances and Drug Products:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/q13-continuous-manufacturing-of-drug-substances-and-drug-products-guidance-for-industry/2724500a-92c1-4369-92e2-13983181dbcf)