James Boiani Quoted in “Combination Product Designations at US FDA Need Faster Appeals, Petition Says”Pharma & MedTech Business Intelligence’s The Pink Sheet Daily March 9, 2017
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 Pharma & MedTech Business Intelligence’s The Pink Sheet Daily, in “Combination Product Designations at US FDA Need Faster Appeals, Petition Says,” by Michael Cipriano. (Read the full version – subscription required.)
Following is an excerpt:
The petition dated March 3 does not name a sponsor, but was filed on behalf of a client that has an appeal which has been “under consideration” by FDA for a year and a half, the party's attorney, James Boiani of Epstein Becker & Green, tells the Pink Sheet.
“With my client it’s been 18 months and counting to get a decision – we’re not even getting into the substance of a decision,” Boiani says. …
Boiani says that FDA has “had a bias” toward assigning products to be regulated by the Center for Drug Evaluation and Research (CDER). According to the agency's fiscal year 2015 annual report to Congress for OCP, the office has assigned 67 combination product assignments and classifications to CDER from fiscal years 2010 to 2015, along with 12 requests to the Center for Biologics Evaluation and Research (CBER).