FDA publishes food registry guidance
This article was originally published in The Tan Sheet
The agency solicits public comment on a draft guidance regarding the reportable food registry, which is slated for implementation Sept. 8. Under RFR, responsible parties - including manufacturers, processors and packagers - will need to alert the agency through its main Web portal that an adulterated food product has the potential to "cause serious adverse health consequences or death to humans," FDA said June 11. The comment period ends June 26. The guidance includes information on when RFR reports must be filed and the information they must include. As specified in the FDA Amendments Act of 2007, RFR reporting requirements exclude infant formula and dietary supplements (1"The Tan Sheet" Sept. 24, 2007)
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The agency requires food facilities to submit to its Web-based reportable food registry cases where a product has a "reasonable probability" of causing severe health problems or death. RFR, which launched Sept. 8 at 1http://rfr.fda.gov/, does not apply to dietary supplements or infant formulas (2"The Tan Sheet" June 29, 2009, In Brief). Michael Taylor, senior advisor to the FDA commissioner, said real-time reporting "enhances FDA's ability to act quickly to prevent food-borne illness." Rep. John Dingell, D-Mich., called RFR "an important first step," but said Congress must still pass food safety legislation. Food firms must comply with RFR requirements immediately, but FDA's guidance says the agency may exercise enforcement discretion until Dec. 8 for parties that make "a reasonable effort to comply.
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