U.S. FDA and NIH Launch Safety Reporting Portal

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) recently launched the Safety Reporting Portal (SRP) website allowing increased accessibility to submit reports concerning FDA-regulated products.

SRP allows even the concerned citizen to submit a safety report related to foods, drugs, and veterinary products.

"As access to this Internet tool increases," said Benjamin L. England, food and drug law professional and founder of FDAImports.com, LLC, "the number of safety reports to FDA will certainly increase as well." FDAImports.com, LLC is a consulting firm founded by Benjamin L. England who has 17 years of experience working inside the FDA.

Currently, to report an adverse event to FDA, even federal investigators, as well as required organizations, must submit duplicate reports to several federal agencies. Each of these reports requires use of different forms, vocabularies, reporting timeframes and criteria. The SRP standardizes 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.

"SRP shows that FDA and NIH are serious about taking action toward uniting and coordinating the diverse federal requirements that are currently in place for the reporting and reviewing of adverse events," England said.

Similar to the old portal system, SRP requires certain organizations 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, to report a safety concern voluntarily. SRP was created with advanced software that makes reporting a problem or concern simpler than ever before.

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