James Boiani Quoted in “Stakeholders: Codevelopment Guide Lacks Clarity on Complementary DX”FDA Week November 4, 2016
James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “Stakeholders: Codevelopment Guide Lacks Clarity on Complementary DX,” by Nicholas Florko. (Read the full version – subscription required.)
Following is an excerpt:
James Boiani, attorney at Epstein, Becker & Green, highlighted the differing timelines for requesting meetings with the device and drug centers, and suggested the agency develop guidance on managing timelines, and describe a process to enable cross-referencing of submissions between centers.
Boiani told Inside Health Policy in July that the guidance was a meaningful step towards achieving consistent reviews across centers.