• Feature ArticlesFeature Articles

    Journey of a Drug From Concept to Approval

    This article reviews the process of getting a new drug to market from the laboratory to the pharmacy. It addresses discovery and the developmental stages along the way, including finding lead compounds (drug discovery), target validation (drug development), and testing through pre-clinical trials, clinical trials, and post-production studies for acquiring marketing and long-term safety data. Introduction A molecule's journey from laboratory concept to a consistent and w...
  • Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...