๐”– Bobbio Scriptorium
โœฆ   LIBER   โœฆ

FDA rules for somatic-cell and gene therapy

โœ Scribed by Fox, Jeffrey L.

Book ID
109910782
Publisher
Nature Publishing Group
Year
1993
Tongue
English
Weight
122 KB
Volume
11
Category
Article
ISSN
1087-0156

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According to Sects. 2 and 3 of the German drug statute, (Arzneimittelgesetz, AMG) gene technology and gene therapy products as well as somatic cell therapy products are regarded as drugs and are therefore subject to Sects. 40 and 41, stipulating the requirements for clinical studies designed to test