Brigid Bondoc spoke toBioWorldabout the U.S. Food and Drug Administration’s draft guidance for predetermined change control protocols (PCCPs).
According to Brigid, developersdon’t need to beutterly averse to including a proposed change to the indication for use in a PCCP program. “I would bring it up with the agency directly [and] try to get an answer” from the FDA about the idea, she recommended, noting that a negative decision from the FDA doesn’t necessarily invalidate the acceptability of the concept for all time.
However, Brigid said that such a move is best when backed by a lot of good homework, which can help drain any impulses on the part of FDA staff to add to the applicant’s premarket load. “Coming in with a proposed plan is always better than trying to get the plan from the FDA” during pre-submission discussions, Brigid said, adding that there is no such thing as stealth where such a move is concerned. “You’re not going to sneak that in without the agency noting.”