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:
How do the regulations distinguish between commercial batch manufacture and guidance for manufacture of the first clinical batches for clinical trials? A New Guidance for Industry was issued in July 2008 (see link below)
Judy would love to hear from you about how this applies to your development product ...
Regulatory Guidance Doc of the month:
"cGMP for Phase I Investigational Drugs"
http://www.fda.gov/downloads/GuidanceComplianceRegulatoryInformation/guidances/UCM070273.pdf
Please contact Dr. Senior with specific questions on regulatory guidances.
