Regulatory order applies to some guidances

FDA guidance documents and other “interpretive” documents may be subject to an executive order on reducing the costs of regulation, according to guidance provided to federal agencies Thursday.

The order requires agencies to eliminate two regulations for each new regulation, and imposes strict cost-cutting requirements for new regulations. When the order was released, lawyers specializing in FDA and administrative law had conflicting opinions about its applicability to FDA guidance documents, and questioned the feasibility of implementing it at FDA (see BioCentury Extra, Jan. 30)...