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 Regulatory Affairs Professionals Society, in “Law Firm Challenges FDA on Combination Product Appeals,” by Michael Mezher.
Following is an excerpt:
James Boiani, a partner at EBG, told Focus he thinks 60 days is a reasonable timeframe for the agency to act on these appeals.
“If FDA makes it a priority, they can take care of it. The agency handles extremely complex appeals for various issues within 30 days. It’s just a matter of getting everyone on the same page regarding timing, and make it a priority for personnel, so it does not sit on someone’s desk,” Boiani said.
He also said it’s difficult to tell how often companies appeal designation decisions.
“It’s hard to say because it’s confidential,” Boiani added. “I would expect that it is rare, but could become more common in the future as FDA starts working through the new provisions of 21st Century Cures regarding designation decisions.”