Cell Therapy & Biologics Web Resources
Below are lists of useful web links for course work and professional needs.
If you find a site that you believe would be useful to other Clinical Trials Professionals, please email that url to clinical@rx.uga.edu.
Let us also know if you find an outdated or broken link so we may replace
it.
Transfer of Therapeutic Products to CDER:
www.fda.gov/cber/transfer/transfer.htm
CBER background information: www.fda.gov/cber/about.htm
CDER Frequently Asked Questions on Drug Development and Investigation -
New Drug Applications: www.fda.gov/cder/about/smallbiz/faq.htm
Manual of Standard Operating Procedures and Policies: Regulatory - License
Applications: www.fda.gov/cber/regsopp/8405.htm
Overview of Regulations for CDRH: www.fda.gov/cdrh/devadvice/overview.html
Information on Premarket Approval Applications: www.fda.gov/cdrh/pmapage.html
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval
and Applications: www.fda.gov/cdrh/mdufma/guidance/1224.html
Cellular Therapy: Potential Treatment for Heart Disease: www.fda.gov/cber/genetherapy/celltherapyheart.htm
Human Gene Therapy and the role of the Food and Drug Administration: www.fda.gov/cber/infosheets/genezn.htm
Alzheimers: Searching for a Cure: www.fda.gov/fdac/features/2003/403_alz.html
Tissue: www.fda.gov/cber/tiss.htm
Vaccine Product Approval Process: www.fda.gov/cber/vaccine/vacappr.htm
- CBER About Us: www.fda.gov/cber/about.htm
