Overcoming Product Development Challenges Through Innovation and Regulation
Posted 01 December 2008 | By
The cost of bringing a new drug to market has surpassed $1 billion (US).1 Simultaneously, pharmaceutical companies are facing budget constraints, empowered patients are demanding high-quality drugs, legislators are demanding increasing oversight to ensure patient safety, and pioneering scientific discoveries are evolving at a rapid pace.2 Faced with increasing regulatory requirements regarding patient safety and the challenges of managing global clinical trials, what can the pharmaceutical industry do to improve the efficiency and cost-effectiveness of drug discovery and development? This article reviews the changing landscape in product development and the establishment of regulatory tools for evaluating product development. It addresses some recent scientific discoveries that can help produce safer, more-effective products, as well as US Food and Drug Administration (FDA) initiatives being implemented to enable greater patient safety.