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GMP News
13 February 2008
 

List of New, Withdrawn and Revised FDA Guidances Published

 
The FDA has published its yearly list of new, withdrawn and revised CDER guidances. This list provides a very good overview about the agency's activities regarding these documents. Guidance documents represent the Agency's current thinking on a particular subject and are an important part to define cGMP. Nevertheless, an alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

You can find the list here:
http://www.fda.gov/cder/guidance/new_revised_withdrawn_2007.pdf
An overview of all published documents can be found here:
http://www.fda.gov/cder/guidance/comprehensive_list.pdf
 

Learn more about the FDA and its regulations in the following ECA course:


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