Will ‘One In, Two Out’ Order Hamper FDA’s Clinical Trial Regs?


Vanessa Burrows said that President Trump’s “one in, two out” rule for new regulations may not jeopardize new human subject protection regulations. “The OMB could determine that harmonization of the FDA and HHS human subject regulations would lead to a reduction in total regulatory costs and burdens,” Ms. Burrows suggested. “The Trump Administration may look to fast track the issuance of rules designed to streamline requirements and reduce duplication, such as any FDA notices of proposed rulemaking harmonizing human subject regulations.”