Issue Date: June 22, 2004
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies
This guidance is one of three guidances intended to assist developers of medical imaging drug and biological products (medical imaging agents) in planning and coordinating their clinical investigations and preparing and submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), abbreviated NDAs (ANDAs), and supplements to NDAs or BLAs. The three guidances are: Part 1: Conducting Safety Assessments; Part 2: Clinical Indications; and Part 3: Design, Analysis, and Interpretation of Clinical Studies.
Download the Guidance Document
