AN OVERVIEW ON USFDA 505(B) (2) NDA AND EU HYBRID MEDICINAL PRODUCTS

Darshil B Shah*, Rashmi Ramchandra Yadav, Dr. Dilip G. Maheshwari

ABSTRACT

Drug development is one of the challenging processes to make profit. Number of promising molecule are wash out in preclinical and clinical studies and some are fail in last stage of marketing, out of them only one molecule is their which clear the all phases of clinical trial and get marketing approval. Pharmaceutical industry invests million of dollars on launching a new molecule and also require 12-15 year of time period for such studies from preclinical studies to marketing approval. Thus pharmaceutical companies are shifting towards the shorter and less costly ways. That can be achieved by 505(b)(2) application of the FD&C Act and Article 10(3) of the directive 2001/83/EC in EU. This pathway is cost effective and have lower risk and used by most of pharmaceutical industry. This review gives the brief overview of hybrid application in EU and US and their effectiveness, which avoids the known possible risk and launches the drug easily with lower cost.

Keywords: FD&C Act (Food, Drug, and Cosmetic Act), EU (European union), 505(b)(2) application, Article 10(3), hybrid application.