Katakam Hepsiba*, G. Ramakrishna, M. V. Nagabhushanam, M. Beena Devi, M. Krishna Snigdha, Enapagundla Brahmareddy

CROSS-REGIONAL EVALUATION OF IND AND CTA FILING REQUIREMENTS IN THE US AND EUROPE

Global pharmaceutical development increasingly requires clinical trials to be conducted across multiple regulatory jurisdictions. The United States (US) and European Union/European Economic Area (EU/EEA) represent two major regulatory environments for investigational medicinal pr...

CROSS-REGIONAL EVALUATION OF IND AND CTA FILING REQUIREMENTS IN THE US AND EUROPE

Global pharmaceutical development increasingly requires clinical trials to be conducted across multiple regulatory jurisdictions. The United States (US) and European Union/European Economic Area (EU/EEA) represent two major regulatory environments for investigational medicinal pr...