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

    India Unveils New Guidelines for Clinical Research Involving Children

    India for the first time in its history has released comprehensive guidance related to the ethical specifics of biomedical research in neonates and children. The pragmatic guidelines from the Indian Council of Medical Research (ICMR) set out general principles that can be applied in most situations to cover the ethical and legal issues that researchers need to consider when carrying out such biomedical research. General Guidance First and foremost, the guidance calls f...
  • Regulatory NewsRegulatory News

    New FDA Guidance Seeks to Protect Unborn from Fathers’ Drug Toxicities

    When the US Food and Drug Administration (FDA) evaluates a drug, it's not just concerned about the drug's effect on the intended patient; it's also concerned about the drug's potential effect on other patients as well. That's the take-home message of a new draft guidance issued by FDA, Assessment of Male-Mediated Developmental Risk for Pharmaceuticals . Background The guidance concerns a long-standing concern for regulators: that a drug might affect an unborn child....
  • Regulatory NewsRegulatory News

    Bioethics Council Calls for Reforms for Clinical Trials Involving Children

    The Nuffield Council on Bioethics has released a report on the ethical issues surrounding clinical research involving children in the UK and EU. The report, which looks at the current status of clinical research and regulations, argues better regulation and greater involvement from children is critical to increasing the number of clinical trials involving children. Background Companies are often reluctant to conduct clinical studies on children due to ethical concerns ...
  • Regulatory NewsRegulatory News

    New FDA Guidance Explains how to Test Drugs on Pediatric Patients

    A new guidance document issued by the US Food and Drug Administration (FDA) established new recommendations for how companies should conduct pediatric studies on new drug and biological products. Testing products in pediatric patients is notoriously difficult. As FDA regulators have reiterated on numerous occasions, children "are not just small adults ," and drug and biological products can behave much differently in pediatric patients compared to how they behave in...
  • 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...
  • Are Medical Countermeasures Meeting the Potential Needs of Children?

    Is the US government doing enough to protect children from the threat of a medical emergency caused by a chemical, biological, radiological or nuclear accident? Not as much as it could be, concludes a new report just published by the Government Accountability Office (GAO), an intra-government watchdog that regularly assesses programs for deficiencies. Background Since the events of September 2011, federal agencies, and particularly the US Food and Drug Administration (F...
  • FDA Finalizes Boxed Warning for Codeine Product Associated with Pediatric Deaths

    US regulators have announced that prescription codeine will now be required to contain a boxed warning contraindicating its use in children who have just undergone a tonsillectomy procedure, saying that deaths and injuries have occurred after some children ultra-rapidly metabolized the drug into morphine. FDA's 20 February 2013 warning follows a preliminary one made in August 2012, in which it said that the drug has been associated with the deaths of at least three chi...
  • NIH to Publish Updated List of Priority Therapeutic Areas for Pediatric Research

    • 25 October 2012
    • By
    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: 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 ...