Brigid Bondoc spoke to BioWorld about the U.S. Food and Drug Administration's draft guidance for predetermined change control protocols (PCCPs).
According to Brigid, developers don't need to be utterly 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."
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