Overview of New and Withdrawn FDA Guidances

The FDA has published its list of new and withdrawn guidance documents for the first 4 months 2009. This list offers a very good overview of the CDER (Center of Drug Evaluation and Research) activities with regard to their guidances. The guidelines reflect the Agency's current thinking on specific topics related to the manufacture, development and registration of medicinal products. Therefore, they represent important modules within FDA's overall cGMP concept.

The list can be found here.

An overview of all currently published documents can be found here

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

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