A Review of New Drug Innovation – Emerging Challenges And Mitigation Strategies

Abstract

The present paper reviews trends in the development and approval of new drugs. The pharmaceutical industry continues to face the problems of high costs of new drug development, FDA’s regulatory regime, and competition from generic drugs. At the same time, consumers’ expectations regarding drug efficacy and safety have continued to increase. This explains why it has become increasingly harder for drug firms to invent new molecules during the last three decades. A few of the resolutions to these problems include strategic drug development data generation, lifecycle planning for a new molecular entity and mergers and acquisitions involving biotechnology and pharmaceutical companies. Moreover, cooperation amongst FDA’s review division and industry is not at desired level to seek development of new safety and efficacy models for enhance productivity in the industry.. KEYWORDS: