FDA CDER announced new Guidance Agenda to be update existing Guidance regulations or to publish new Guidance in calendar year 2011.
There are a number of really interesting topics on the agenda like:
- Bioanalytical Methods Validation
- Development of Drugs in Combination
- Contract Manufacturing
- Control of Components
- Control of Highly Potent Compounds
- Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs
- Medical Gases, General CGMP
- Non-Penicillin Beta-Lactam Contamination
- Outsourcer Pharmacy Operations Compliance Policy Guide
- Pharmaceutical Component Quality Control
- Pharmaceutical Manufacturing Statistics
- Prevention and Control of Viral Contamination
- Compliance Policy Guide Section 490.200 for FDA Staff: Parametric Release - Drug Products Terminally Sterilized by Moist Heat
- Good Pharmacy Compounding Practices for Sterile Drug Products
