# Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/antibacterial-drug-products-use-of-noninferiority-studies-to-support-approval/b2b05847-3e9e-404c-8b11-6bcb28661443

> FDA guidance document: Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval. Issue date: November 29, 2010. Get complete insights and analysis.

---

## Details

- Title: Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
- 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: 2010-11-29
- Last Changed: 2020-04-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2007-D-0150">FDA-2007-D-0150</a>

## Related Documents

- [Acute Bacterial Skin and Skin Structure Infections:  Developing Drugs for Treatment](https://www.globalkeysolutions.net/guidances/guidance-document/acute-bacterial-skin-and-skin-structure-infections-developing-drugs-for-treatment/ddbe2cf0-2e38-4e65-88f4-c140b1c9a825)
- [Label Comprehension Studies for Nonprescription Drug Products](https://www.globalkeysolutions.net/guidances/guidance-document/label-comprehension-studies-for-nonprescription-drug-products/db55d737-aeaa-4c66-b24c-5295ebc3bf15)
- [Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals](https://www.globalkeysolutions.net/guidances/guidance-document/nonclinical-evaluation-of-late-radiation-toxicity-of-therapeutic-radiopharmaceuticals/92fb275a-6c59-437b-9f82-274a46b009a0)
