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We have a drug product approved for use in adults. Our pediatric study requirement was deferred and was a post marketing requirement. We are conducting the study now.
When we submit the study data and the proposed updated labeling to expand the indication to include pediatric patients, is the supplement a Labeling Prior Approval Supplement or an Efficacy Supplement? The review timelines for these are different, so it makes a difference.
The FDA Guidance Changes to an Approved NDA or ANDA (April 2004, CMC) states that the following labeling changes require the submission of a Prior Approval Supplement (presumably a Labeling PAS):
1. Changes based on postmarketing study results, including, but not limited to, labeling changes associated with new indications and usage.
5. Revision (expansion or contraction) of population based on data.
21 CFR 314.3 "Efficacy supplement" provides the following definition:
Efficacy supplement is a supplement to an approved NDA proposing to make one or more related changes from among the following changes to product labeling:
(1) Add or modify an indication or claim;
(5) Significantly alter the intended patient population;
Thank you in advance for your response.