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  • Regulatory NewsRegulatory News

    Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes

    A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations. Background Pediatric study requirements are included in both the Pediatric Research Equity Act (PREA), which requires biopharma companies to ...
  • Regulatory NewsRegulatory News

    NIH Wants Safety, Efficacy of Viagra, Epogen and Other Drugs Tested in Children

    • 25 August 2014
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    The National Institutes of Health (NIH) has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on. Background Historically, many companies seeking product approval in the US avoided clinical studies involving children, wary of ethical problems, a lack of incentives and the potential consequences if testing uncovered new problems. As a res...
  • Regulatory NewsRegulatory News

    After Months of Silence, FDA Returns to 'Name and Shame' Strategy on Pediatric Trial Compliance

    In 2013, the US Food and Drug Administration (FDA) launched a new webpage seemingly intended to shame companies into meeting their pediatric study commitments under the  Pediatric Research Equity Act ( PREA ). But after an initial deluge of postings, FDA's updates to the page have all but halted, with just five letters posted to the page after its launch, and none within the last six months. Now FDA has posted its first letter to the page in more than half a year detail...
  • Researchers: Need for More Neonate-Specific Clinical Drug Research

    Researchers writing in the research publication Journal of Pediatrics (JP) are calling for the increased inclusion of neonates in pediatric drug trials, arguing that the sub-group is highly underrepresented, potentially to the detriment of newborn children. The article , scheduled to be published this week, takes note of an oft-discussed problem: Pharmaceutical products are rarely studied in children to the same extent as adults, resulting in many of those products be...
  • NIH to Publish Updated List of Priority Therapeutic Areas for Pediatric Research

    • 25 October 2012
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    The National Institutes of Health (NIH) is preparing to release a new report detailing the therapeutic needs of pediatric patients under the Best Pharmaceuticals for Children Act (BPCA) , a piece of legislation aimed at promoting the safe prescribing of medicines for children. The 2002 law, similar to the Pediatric Research Equity Act (PREA) , allows FDA to work with sponsors of certain therapeutic products to conduct postmarketing studies involving children in ret...
  • Study: Pediatric Clinical Trials Remain Scarce

    • 25 July 2012
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    An upcoming study in the medical journal Pediatrics finds pediatric clinical trials to be lacking, especially for conditions where children are well represented among those most likely to benefit from a medical product, reports Reuters . The study, led by author Dr. Florence Bourgeois, looked at more than 2,400 clinical trials conducted in the last five years and their respective enrollment of children. The studies were notable in that they were all related to condi...
  • Study: Pediatric Clinical Trials Guilty of Publication Bias, NIH Falling Short of Obligations

    An examination of 2,385 completed pediatric clinical trials has found 71% were never published, reports Pharmalot . The study, Pediatric Clinical Trial Registration and Trial Results: An Urgent Need for Improvement , was published in the 23 April edition of the medical journal Pediatrics . The study looked at 3,428 closed studied involving children, of which 2,385 were completed, 28 suspended, 125 terminated and 38 withdrawn. The study's authors, Tatyana Shamliya...
  • Senators Release Plan to Improve Pediatric Device, Drug Safety

    • 18 April 2012
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    Sens. Jack Reed (D-RI), Lamar Alexander (R-TN), Patty Murray (D-WA) and Pat Roberts (R-KS) introduced new legislation they said will make "critical" improvements in the safety of medical products taken or used by children, reports The Chattanoogan . The legislation, The Better Pharmaceuticals and Devices for Children Act (BPDCA) , aims to address a shortage of information about how pharmaceuticals and medical devices work in children, said Reed. "This legislation wi...
  • PREA, BPCA Reauthorization Bill Introduced in House of Representatives

    A bipartisan trio of Representatives introduced a bill that would reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) , marking an attempt to further a program that has been widely praised for establishing greater safety for pediatric medications. The bill, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Ph...
  • IOM Report: Clinical Trials in Kids Working

    • 02 March 2012
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    An Institute of Medicine report says laws motivating drug makers to test medicines in children have found information that has helped pediatric physicians give better care. The report cautions that studies in newborns and long-term drug usage as kids get older continue to be limited, according to a report by MedPage Today . Congress passes two federal laws, the Best Pharaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), to provide incent...
  • IOM: Legislation Has Led To Safer Medicines For Children, More Work Needed

    An Institute of Medicine (IOM) report released 29 February praises the effects of the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) on safe and effective medicinal practices in children, but calls for further expansion of pediatric studies . The report, entitled Safe and Effective Medicines for Children: Pediatric Studies Conducted Under BPCA and PREA, was commissioned at the request of the US Food and Drug Administratio...
  • PDUFA Hearings Highlight Support and Concerns About Legislation

    The US House Committee on Energy and Commerce (E&C) held a hearing on 1 February 2012 on the Prescription Drug User Fee Act (PDUFA) , the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research and Equity Act (PREA) . The hearing highlighted the broad support that all three pieces of legislation have in Congress. The hearings also hinted at certain issues that may come to dominate the debate over the coming months, including conflict of interest ...