ICH Guidance and
FDA Regulatory Updates
ICH/FDA
Guideline CDs - to obtain your free CDs, copy and paste the titles of
interest, listed immediately below, into the email created with the
following link,
ICH-guidelines@amarexcro.com
- Anti-microbials
- Cancer Endpoints
- Clinical Trial Design
- Electronic Submissions
- European Union Clinical Trials
- Infectious Diseases
- IRB and DSMB
- Medical Devices
- Monoclonals
- Part 11 Compliance
- Pre-Clinical Testing
- Safety Reporting
- Special Procedures and Meetings
- Vaccine Development
White Papers / Abstracts /Summaries of FDA issues relevant to clinical trial design and conduct:
Please check back at a later date.