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PUBLICATIONS - US Biotechnology Regulations Handbook published by the Food and Drug Licensing Institute:

This article was originally published in Clinica

Executive Summary

The Food and Drug Licensing Institute has published the US Biotechnology Regulations Handbook, a two-volume set providing information on how biotechnology products are regulated. The first volume explains how US leading regulatory bodies such as the FDA regulates biotech products and what one should know about export controls. The second volume presents every major Federal Register notice, proposed policy, and guidance relevant to the regulation of biotech products. Contact the FDLI in the US for more information. Tel: +1 202 371 1420. Fax: +1 202 371 0649.

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