Do FDA ‘guidance’ documents skirt the regulatory process?
Story Date: 12/13/2017

 

Source: Dan Flynn, FOOD SAFETY NEWS, 12/12/17


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 time and expense involved,” says…

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