News Column

New Findings from Harvard University Describe Advances in FDA Actions

June 23, 2014

By a News Reporter-Staff News Editor at Pharma Business Week -- Investigators publish new report on FDA Actions. According to news originating from Boston, Massachusetts, by NewsRx correspondents, research stated, "Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development."

Our news journalists obtained a quote from the research from Harvard University, "The current state of trial evidence underpinning the approval of pediatric devices remains poorly described. We identified all high-risk (ie, class III) devices approved through the premarket approval or humanitarian device exemption pathways for therapeutic use in children between 2008 and 2011. We collected key information on clinical trial design (randomization, blinding, controls, and types of end points) as well as age distribution of trial participants. We also identified US Food and Drug Administration (FDA)-mandated postmarketing trials. Twenty-two devices were approved for use in children via the premarket approval pathway and 3 via the humanitarian device exemption pathway. Twenty-two (88%) qualified as pediatric despite minimum approval ages of 18 years (the FDA Center for Devices and Radiologic Health considers patients 18-21 years old as pediatric). Most devices were approved on the basis of nonrandomized (59%), open-label (68%) studies with surrogate effectiveness end points (86%). Overall, 21 (84%) devices were not studied in any patients FDA for 19 (76%) devices, although only 3 (18%) required enrollment of pediatric patients. Most high-risk pediatric devices are approved on the basis of trials in patients 18 years old, with few pediatric patients exposed to the devices before market availability."

According to the news editors, the research concluded: "Few postmarketing studies require additional study in pediatric patients."

For more information on this research see: Postmarketing Trials and Pediatric Device Approvals. Pediatrics, 2014;133(5):E1197-E1202. Pediatrics can be contacted at: Amer Acad Pediatrics, 141 North-West Point Blvd, Elk Grove Village, IL 60007-1098, USA. (Elsevier -; Pediatrics -

The news correspondents report that additional information may be obtained from T.J. Hwang, Harvard University, Sch Med, Dept. of Pediat, Boston, MA 02115, United States. Additional authors for this research include A.S. Kesselheim and F.T. Bourgeois (see also FDA Actions).

Keywords for this news article include: Boston, Pediatrics, FDA Actions, Massachusetts, United States, North and Central America, Government Agencies Offices and Entities

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC

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Source: Pharma Business Week

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