The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • 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...
  • FDA to Antibiotic Company: The Kids in your Advertisement Misbrand your Drug

    The US Food and Drug Administration (FDA) last week sent pharmaceutical company Pernix Therapeutics Holdings a warning indicating that one of its marketing pieces failed to contain sufficient warnings, contraindications and risk information otherwise contained in the drug's FDA-approved labeling, making it misbranded. Pernix's Cedax The warning, made public by FDA's Office of Prescription Drug Promotion (OPDP) on 20 December 2013 in the form of an Untitled Letter, refer...
  • How do Kids Interpret Drug Advertising? Proposed FDA Study Aims to Find Out, Refine New Approaches

    The intersection between kids and pharmaceutical advertising is nothing if not a sensitive subject. When the US Food and Drug Administration (FDA) unexpectedly eased advertising restrictions in 1997, allowing pharmaceutical companies to market their products directly to consumers (DTC) for the first time in decades, a tsunami of advertising was released onto the public. Background While advertising spending by the industry peaked in 2006 at $5.4 billion, the industry s...
  • 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: Clinical Trials Lag in Enrollment of Children

    • 02 October 2012
    • By
    Are the pharmaceutical industry and the National Institutes of Health doing enough to enroll children in clinical trials? No, claims a new study published in the journal Pediatrics and supported by the Clinical Trials Transformation Initiative (CTTI), an organization that partners with the US Food and Drug Administration (FDA) and numerous other government agencies. The study, " Status of the Pediatric Clinical Trials Enterprise: An Analysis of the US ClinicalTrials.go...
  • European Commission Issues Draft Pediatric Regulation Report

    The European Commission is requesting public comment on its draft report to the European Parliament on the five years of experience since the Pediatric Regulation entered into force in January 2007.  The Regulation was adopted in response to a lack of suitable, authorized medicinal products for children in the EU. Studies had shown that over 50% of the medicines used for children might not have been tested in pediatric populations, leaving providers not choice bu...
  • EMA Opens Consultation on Proposed Pediatric Development Framework

    The European Medicines Agency (EMA) is opening a public consultation on a newly released report in which it calls for a new framework to incorporate the views of children into the review of clinical trial plans before the Pediatric Committee (PDCO). The report, " Concept paper on the involvement of children and young people at the PDCO ," is aimed at meeting the requirements of the Charter of Fundamental Rights of the EU, which states that member states should take into ...
  • Study: Most Drugs Lacking Information on Adequate Pediatric Use

    • 09 May 2012
    • By
    A study conducted by researchers at the US Food and Drug Administration (FDA) finds fewer than half of all pharmaceutical products on the market do not contain any information for how the drug should be used safely in pediatric populations, reports Reuters . The study, published in the Journal of the American Medical Association , notes just 46% of products listed in the electronic Physicians' Desk Reference contained information to ensure safe pediatric use, notes Me...
  • 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...