# Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/developing-medical-imaging-drug-and-biological-products-part-3-design-analysis-and-interpretation-of-clinical-studies/560bad6d-d575-4a09-84e7-a396f541a476

> FDA guidance document: Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies. Issue date: June 22, 2004. Get complete insights and analysis.

---

## Details

- Title: Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies
- 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: 2004-06-22
- Last Changed: 2020-04-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1998-D-0035">FDA-1998-D-0035</a>

## Related Documents

- [Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments](https://www.globalkeysolutions.net/guidances/guidance-document/developing-medical-imaging-drug-and-biological-products-part-1-conducting-safety-assessments/7bd6bcd1-17d8-43a5-90f7-417b39f3ebf4)
- [Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/clinical-studies-section-of-labeling-for-human-prescription-drug-and-biological-products-content-and-format-guidance-for-industry/8675c759-b657-4818-9bed-199de1148828)
- [Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications](https://www.globalkeysolutions.net/guidances/guidance-document/developing-medical-imaging-drug-and-biological-products-part-2-clinical-indications/b799f895-2a25-481d-85aa-d8b5f1322a85)
