FDA announced new Guidance Docs for 2011

FDA announced new Guidance Docs for 2011

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