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Posted On: 11/25/2019 10:09:56 AM
Post# of 72441
This link provides the list of indications that are granted an automatic waiver from pediatric studies/trials. Note that oral mucositis is not on the list, so IPIX had to request a review by FDA. While it is likely that it was a relatively easy waiver to get for OM, it still reduces the potential trial size and I imagine an interested party (and IPIX) would want to make sure it was granted before moving forward.
https://www.fda.gov/media/101440/download
https://www.fda.gov/media/101440/download
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