Pediatric Studies of Meropenem Conducted in Accordance With Section 409I of the Public Health Service Act; Establishment of Public Docket

摘要

The Food and Drug Administration (FDA) is announcing the opening of a public docket to make available to the public a report of the pediatric studies of meropenem that were conducted in accordance with section 409I of the Public Health Service Act (PHS Act) and submitted to the Director of the National Institutes of Health (NIH) and the Commissioner of Food and Drugs.