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Glomerular filtration rate (GFR) in preterm neonates is markedly reduced, with the most premature infants (born at ∼26 weeks’ gestational age) showing values several-fold lower than those of term neonates at 1 month of age
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The FDA's briefing documents proposed the same conclusion for each of the seven peptides: do not add them to the 503A Bulks List
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