James Boiani Quoted in “FDA’s New Combo Products Pilot Distinct from Planning Office Proposals”FDA Week August 5, 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 “FDA’s New Combo Products Pilot Distinct from Planning Office Proposals,” by Nicholas Florko. (Read the full version – subscription required.)
Following is an excerpt:
One combination products attorney praised FDA's new pilot program. "I think the improvements being targeted by the Council are on the money," wrote James A. Boiani, a member of the law firm Epstein, Becker & Green, in a statement to Inside Health Policy.
Boiani said the announcement demonstrated FDA is interested in developing the ICCR process in a transparent fashion.
"I get a sense from this announcement and other recent communications about the Council that its opting for a more engaged, collaborative approach, which is welcome news; when it comes to developing regulatory policy, the best results come from engagement with stakeholders, not work behind closed doors," wrote Boiani.