It is an unfortunate reality that many diseases and conditions affect such small numbers of patients that, when a sponsor develops a drug or biological product to treat them, relatively little return on investment is generated to offset the high development costs....
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Oncology & Hematology
The Multi-Faceted World of Clinical Trial Matching in Precision Oncology Studies
The success of clinical trials is contingent upon finding participants who meet certain criteria, ensuring that the resulting study data are meaningful and relevant to the target patient population. Clinical trial matching is the process of identifying and connecting potential...
Development of liquid biopsies for early cancer detection requires careful planning. Understanding the regulatory environment and the challenges of conducting the studies needed for approval is integral to success. Here, we review the regulatory pathways for in vitro diagnostics (IVDs)...
Cancer is the leading cause of death worldwide, accounting for nearly one in every six deaths. According to a recent paper, an estimated 15% of cancer-related deaths could be avoided by early disease detection.1 However, there are currently very few...
GxP refers collectively to several different types of “good practice” quality guidelines and regulations, each serving a specific purpose.
In a fast-paced digital world, healthcare has had to adapt to better serve consumers who increasingly prefer the convenience of web- or app-based services to in-person assistance. Mobile health (or mHealth) solutions provide increased access to care, making it easier...
Premier Research's regulatory strategists specializing in the US FDA’s 505(b)(2) approval pathway are often asked how a sponsor can recover from a pre-IND meeting that doesn’t go as planned. While we firmly believe that setbacks can be turned into opportunities...
Oncology & Hematology
Rare Oncology and the FDA: Taking the Guesswork Out of Expedited Pathways
Rare cancers account for 25-30 percent of all new cancer diagnoses and 25 percent of cancer deaths.1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant...
The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. With many steps in between, each as important as the next, multiple factors regarding development strategy...
All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers. Periodically, the FDA updates these forms to...