New FDA Guidance Documents in Calendar Year 2011

On January 26, 2011 the FDA issued the Guidance Agenda: New & Revised Draft Guidances CDER plans on publishing during the calendar year 2011.

The document is structured in different categories. With regard to Current Good Manufacturing Practices (CGMPs)/Compliance a number of documents are listed. Some of them will be of high interest for industry, like:

  • Contract Manufacturing
  • Control of Highly Potent Compounds
  • Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs
  • Non-Penicillin Beta-Lactam Contamination
  • Pharmaceutical Component Quality Control
  • Compliance Policy Guide Section 490.200 for FDA Staff: Parametric Release - Drug Products Terminally Sterilized by Moist Heat

In the category "Chemistry" the FDA plans on developing among others the following Guidelines:

  • CMC Postapproval Changes Reportable in an Annual Report and
  • Comparability Protocols for Approved Drugs: CMC Information

Source: Federal Register and CDER Webpage

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