Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application.
In September 2010, the US Food and Drug Administration (FDA) published a final rule governing the requirements for expedited safety reporting for products subject to an investigational new drug application. The rule clarified the types of safety information that qualify for expedited reporting. Its intent was to improve the overall quality of safety reporting by reducing the number of uninterpretable individual reports sent to the FDA and clinical investigators. In December 2011, we surveyed pharmaceutical and biotechnology sponsors regarding their safety reporting practices. We convened a group of experts and a biostatistics work group to review the survey results and identify gaps between current practice and the final safety reporting rule. Most sponsors had not changed their approach to expedited reporting of serious adverse events. We devised recommendations to help sponsors optimize their premarket safety systems to reduce the number of uninformative expedited reports and ensure recognition of important safety issues for an investigational drug as early as possible in development.
Duke Scholars
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- Statistics & Probability
- 4905 Statistics
- 3214 Pharmacology and pharmaceutical sciences
- 1117 Public Health and Health Services
- 0104 Statistics
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Statistics & Probability
- 4905 Statistics
- 3214 Pharmacology and pharmaceutical sciences
- 1117 Public Health and Health Services
- 0104 Statistics