The Food and Drug Administration (FDA) is publishing a summary report of the pediatric studies of meropenem conducted in accordance with the Public Health Service Act (the PHS Act) and is making available requested labeling changes for meropenem. The Agency is making this information available consistent with the PHS Act.
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Pediatric Studies of Meropenem Conducted in Accordance With the Public Health Service Act; Availability of Summary Report and Requested Labeling Changes
The Food and Drug Administration (FDA) is publishing a summary report of the pediatric studies of meropenem conducted in accordance with the Public Health Service Act (the PHS A...
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80 FR 30467
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“Pediatric Studies of Meropenem Conducted in Accordance With the Public Health Service Act; Availability of Summary Report and Requested Labeling Changes,” thefederalregister.org (May 28, 2015), https://thefederalregister.org/documents/2015-12848/pediatric-studies-of-meropenem-conducted-in-accordance-with-the-public-health-service-act-availability-of-summary-report.