PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA
The FDA Law Blog
JUNE 11, 2023
However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected. Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. Still, however, it appears FDA has had enough of these 16%.
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