Current FDA Opinions on Regulatory Affairs, Inspections and GMP

GMP News No. 578

GMP News
22 July 2005
 

Current FDA Opinions on Regulatory Affairs, Inspections and GMP

 
Every now and then, FDA's Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) conduct a public "FDA Drug Educational Forum". In the course of these events, FDA speakers give an overview of current requirements on regulatory affairs, inspections and GMP. The slides of the most recent event have been published on CDER's website. They can be downloaded here. Due to the wide range of topics, the presentations are of interest to you if you have to stay informed about FDA's current thinking.

Author: Dr. Ulrich Herber, CONCEPT HEIDELBERG
  

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