Guidance
University of Pittsburgh Guidance Documents
FDA Guidance Documents
- Center for Drug Evaluation and Research Guidance Documents
- Center for Biologics Evaluation and Research Guidance Documents
- Center for Devices and Radiological Health Guidance Documents
- Dockets Open for Comment
- Preparing a Claim of Categorical Exclusion or an Environmental Assessment
- Clinical Trials Registration Requirements
Where to Begin
Am I required to submit an IND or IDE application?