Sunday, 13 October 2013

Is Orange Book and Orange Guide are same?

 
 
 
Orange book VS  Orange Guide
 
 

 
Orange Book
Orange Guide
“Orange book” is published by the FDA's Centre for Drug Evaluation and Research (CDER).
 
“Orange guide” is published by MHRA.
“The Orange Book" is actually the U.S. Food and Drug Administration's (FDA) official listing of Approved Drug Products with Therapeutic Equivalences.
 
“Orange guide” contains the requirements of Good Manufacturing Practice (It
contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation).
“The Orange Book” lists drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
“Orange Guide”, provide guidance for those who involved in the manufacture and distribution of medicines in Europe.

 


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