Useful Links
- ICH E3 - Structure and Content of Clinical Study Report
- ICH E9 - Statistical Principles for Clinical Trials
- FDA 2008 Guidance - ISE
- Guidance for Industry M4E: The CTD - Efficacy
- FDA Guidance - Location of ISS/ISE within CTD
- FDA Guidance - Clinical Safety Review of an NDA or BLA
- CTD Headings and Hierarchy
- FDA eSubmission Website
- FDA Data Standards Resources
- FDA CDER (including ICH) Guidances
- FDA CBER Guidances
- ClinicalTrials.Gov
- Clinical Data Interchange Standards Consortium (CDISC)
- SAS v9.1.3 Online Document
- FDA EOP2A Meetings
- FDA Exposure-Response Design and Analysis
- FDA Drug-Induced Liver Injury
- FDA Organizational Chart
- FDA/CDER Office of New Drugs and Office of Biostatistics Organizational Chart
- FDA Advisory Committee Calendar
- FDA CDER Manuals of Policies & Procedures
- Code of Federal Regulations Title 21