US FDA and NIH Launch Web-based Safety Reporting Portal
US FDA and the National Institutes of Health (NIH) launch the Safety Reporting Portal (SRP) web site allowing increased accessibility to submit reports concerning FDA regulated products.
Product Manufacturers, Processors, Packers, Warehouses, Researchers, and Health Care Professionals already had the ability (and sometimes the duty) to report safety problems to FDA.
Currently, in order to report an adverse event to FDA, one must submit duplicate reports to several federal agencies. Each of these reports requires use of different forms, vocabularies, reporting time frames and criteria.
The SRP standardises all submitting requirements across commodities, industries and market participants. Previously, multiple agencies were receiving the same safety report in varying formats. This had the potential to cause confusion among government authorities concerning which department should investigate and potentially take enforcement action.
Similar to the old portal system SRP requires certain organisations to submit Mandatory Reports relating to Reportable Foods, Animal Drug Safety, and Gene Transfer Research. SRP now enables anyone who has internet access, including consumers, the ability to report a safety concern voluntarily. SRP was created with advanced software that makes reporting a problem or concern simpler than ever before.
