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

See the full agenda on the CDERs Homepage.