Sunday 10 February 2013

FDA: proposed guidance documents for 2013

The FDA has issued its work schedule for 2013. Listed below are the guidance documents that it intends to produce or update during 2013:
  • Quality Systems Approach to Pharmaceutical cGMP Regulation
  • Uniformity of In-Process Mixtures
  • Control of Highly Potent Compounds
  • Contract Manufacturing Arrangements for Drugs: Quality Agreements
  • Submission of Field Alert Reports and Biological Product Deviation Reports

For further details, see FDA

Posted by Tim Sandle

1 comment:

  1. None of these seems any surprise to me as all are consistently in the news - usually for the wrong reasons!

    John White
    The Quality Compliance Partnership Ltd


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