Orange
book VS Orange Guide
|
Orange
Book
|
Orange
Guide
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“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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