Innovative Early Development Regulatory Approaches: expIND, expCTA, Microdosing
Clinical Pharmacology & Therapeutics December 19, 2007 WT Robinson 37 citations
Regulatory agencies like the FDA and European Medicines Agency seek more efficient drug development. One resulting initiative is the creation of guidance documents for exploratory investigational new drugs (INDs) and clinical trial applications (CTAs). This article reviews the history of those guidances and the industry's experience using them so far.