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  • Regulatory NewsRegulatory News

    Majority of Open PMRs and PMCs Progressing on Schedule, FDA Report Shows

    The majority of the open postmarket requirements (PMRs) and commitments (PMCs) in the US Food and Drug Administration’s (FDA) database continues to progress on schedule, according to data from the latest report released Friday. Background A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that ...
  • Regulatory NewsRegulatory News

    FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements

    FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations. The situation, according to Gottlieb, arises if sponsors received an orphan designation for a pediatric subtype of an otherwise common and non-orphaned adult disease. For example, with a condition like inflammatory bowel disease (IBD), a drug may be approved to...
  • Regulatory NewsRegulatory News

    FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement

    The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT). FDA said in a letter sent to the company in late July that it has not yet submitted its pediatric assessment, which was identified in the BLA’s approval letter fro...
  • 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

    Pediatric Study Plans: FDA Unveils Revised Draft Guidance

    The US Food and Drug Administration (FDA) on Tuesday released updated draft guidance intended to help pharmaceutical sponsors submit pediatric study plans, including what should be included in the plans and how they should be submitted. This revision, which FDA says was based largely on public comments, includes additional clarifications on the 2013 draft guidance, such as new information on what constitutes a materially incomplete initial pediatric study plan (iPSP), th...
  • Regulatory NewsRegulatory News

    Consumer Advocacy Group Warns on Orphan Provisions in 'Cures' Act

    Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate. The provisions in question would add an additional six months of marketing exclusivity for approved drugs that later go on to be approved to treat rare diseases. The extended period of exclusivity would apply to all indicati...
  • Regulatory NewsRegulatory News

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

    • 25 August 2014
    • By
    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...
  • Study: Pediatric Clinical Trials Remain Scarce

    • 25 July 2012
    • By
    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
    • By
    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...