Resources
Industry Guidelines
Click here for current information on FDA guidelines for medicines regulated by CDER. You will find these useful links:
- Regulatory and Scientific Guidances
- Specific Regulatory Initiatives
- Legislation
- Submitting Applications for New Drug Products
- International Activities
- CDER Policies and Procedures
- Compliance Activities
- Freedom Information Act
- Useful Resources
Click here for information concerning development areas regulated by CBER:
- Allergenics
- Blood
- Cellular and Gene Therapy
- Devices
- Tissues
- Vaccines
- Xenotransplantation
- Consumer and Health Care Information
- eFOIA Reading Room
- Industry
- Product Information
- Scientific Expertise and Research
Current discussion topic:
What is the role of Quality Assurance in a small drug development company? How much is 'just enough'? What specific dangers is a company looking at by walking too fine a line between saving costs and sacrificing on quality?
Judy would love to hear your opinion....
ICH Guidance Doc of the month:
"Quality Systems Approach to Pharmaceutical cGMP Regulations"
http://www.fda.gov/cder/guidance/index.html
Please contact Dr. Senior with specific questions on regulatory guidances.
