Pre-Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products

Conclusions: This analysis showed the importance of early communication with FDA during development, and small companies with limited regulatory experience may gain the greatest benefit from early communication with FDA.

http://dij.sagepub.com/cgi/content/abstract/49/3/434?rss=1

Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Vu, H. H., Pariser, A. R. Tags: Regulatory Science Source Type: research