The FDA is likely to see its rules and guidances come under increased scrutiny now that President Barack Obama has signed an executive order intended to overhaul all of the country’s federal regulations. Obama ordered all government agencies to conduct a cost-benefit analysis before issuing a new regulation and to develop any regulations that do go forward in the least burdensome manner possible and with specific performance goals. In addition, agencies should seek out and assess all available alternatives to direct regulation before issuing any new rules.
Drug Industry Daily