๐”– Bobbio Scriptorium
โœฆ   LIBER   โœฆ

Regulation of Somatic-Cell Therapy and Gene Therapy by the Food and Drug Administration

โœ Scribed by Kessler, David A.; Siegel, Jay P.; Noguchi, Philip D.; Zoon, Kathryn C.; Feiden, Karyn L.; Woodcock, Janet


Book ID
120388264
Publisher
Massachusetts Medical Society
Year
1993
Tongue
English
Weight
817 KB
Volume
329
Category
Article
ISSN
0096-6762

No coin nor oath required. For personal study only.


๐Ÿ“œ SIMILAR VOLUMES


Guidelines for the design and implementa
โœ A. Lindemann; F. M. Rosenthal; R. Mertelsmann; S. Hase; P. Markmeyer ๐Ÿ“‚ Article ๐Ÿ“… 1995 ๐Ÿ› Springer ๐ŸŒ English โš– 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