As an advisory board member of Bloomberg BNA’s Medical Research Law & Policy Report, Robert E. Wanerman, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted throughout the publication’s outlook for the coming year titled “Common Rule Update Expected to Dominate Regulatory Landscape in 2016.”
Following is an excerpt:
While he didn’t specifically name 21stCentury Cures, Wanerman said the potential for coordinating or consolidating regulatory oversight of clinical research will be another important issue for 2016. The House-passed bill includes language that calls for the FDA and the OHRP to harmonize their regulations and directs the HHS to find ways to reduce regulatory duplication. …
“The report by the National Academy of Sciences, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21stCentury … lays out a strong case for revising the current fragmented clinical research regulatory structure to match how research is conducted,” Wanerman said. “The approach has some support in Congress, and this effort should be carefully monitored by stakeholders.”
