Guidelines for the design and implementa
✍
A. Lindemann; F. M. Rosenthal; R. Mertelsmann; S. Hase; P. Markmeyer
📂
Article
📅
1995
🏛
Springer
🌐
English
⚖ 443 KB
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