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 “Combo Products Won’t Get Special Review Pathway at US FDA Anytime Soon,” by Michael Cipriano and Sue Darcey. (Read the full version – subscription required.)
Following is an excerpt:
The agency has historically had a bias toward assigning products to be regulated by the drug center, says James Boiani, an attorney with Epstein Becker and Green, most likely because device-regulated products have a less demanding regulatory pathway. ... One of Boiani’s clients filed a citizen petition with FDA March 3, stating that FDA’s Office of Combination Products should set deadlines for appeals of designation decisions, in an effort to cut down on delays.
