Follow-On Biologics: Background & Issues

ISBN-13: 9781611220766 / Angielski / Twarda / 2011 / 148 str.

Daniel J Gutiérrez

Opis

A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. This book provides a brief introduction to the relevant law, the regulatory framework at the FDA, and the scientific challenges for the FDA in considering the approval of follow-on biologics.