Overview of new and withdrawn FDA Guidances 2009

The FDA has published its annual list of new and withdrawn guidance documents. This list gives a very good overview of the CDER's (Center of Drug Evaluation and Research) activities with regard to these guidances. The guidances reflect the Agency's current thinking on specific topics concerning the manufacture, development and registration of medicinal product. Therefore, they are a vital component within the FDA's overall cGMP concept.

The list can be found here.
You will find an overview of all presently published documents if you follow this link

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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