ARTICLE
1 September 2023

Attorney Says PCCPs With Change In Indication For Use Not Completely Impracticable

MF
Morrison & Foerster LLP

Contributor

Known for providing cutting-edge legal advice on matters that are redefining industries, Morrison & Foerster has 17 offices located in the United States, Asia, and Europe. Our clients include Fortune 100 companies, leading tech and life sciences companies, and some of the largest financial institutions. We also represent investment funds and startups.
Brigid Bondoc spoke to BioWorld about the U.S. Food and Drug Administration's draft guidance for predetermined change control protocols (PCCPs).
United States Food, Drugs, Healthcare, Life Sciences
To print this article, all you need is to be registered or login on Mondaq.com.

Brigid Bondoc spoke to BioWorld about the U.S. Food and Drug Administration's draft guidance for predetermined change control protocols (PCCPs).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."

Read the full article (subscription required).

Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP. All rights reserved

We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.

See More Popular Content From

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More