Those guidance documents the Food and Drug Administration hands out to food manufacturers and others don’t mean as much as they once did. The Department of Justice has changed its policy so government lawyers will no longer rely on guidance documents to establish civil law infractions.
The policy change was
Continue Reading Sessions clears way for food companies to ignore FDA guidance
The Food and Drug Administration’s penchant for “guidance” documents as opposed to formal rulemaking needs to end, according to a business-oriented public interest legal foundation.
“FDA’s turn away from notice-and-comment rulemaking has an obvious motive: Formal rulemaking can be quite cumbersome, and FDA would prefer where possible to avoid the
Continue Reading Do FDA ‘guidance’ documents skirt the regulatory process?
