• Feature ArticlesFeature Articles

    Orphan Drug Regulations in Europe

    This article defines orphan drugs and provides an overview of the evolution of European orphan drug regulations. Incentives are addressed including orphan drug legislation and policy, the criteria for orphan status designation and the authorization process for gaining an orphan drug designation in EU. Introduction “Patients suffering from rare conditions should be entitled to the same quality of treatment as other patients.” This sentiment provides the basis in European...
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    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...
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    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...