• Regulatory NewsRegulatory News

    Australian TGA Taking a More Discerning Approach to Notified Bodies

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits  for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used the...
  • Study: Nearly Third of all Clinical Trials Results Never Published

    • 30 October 2013
    The result of nearly one in three large clinical trials remain a mystery five years after they end, claims research published this week in the British Medical Journal (BMJ) , raising significant questions about the obligations companies have to the hundreds of thousands of patients who participated in these trials. Researchers looked at 585 "large" clinical trials-trials with 500 or more registered patients-registered with ClinicalTrials.gov as of January 2009. Of the 5...
  • Diabetes Drugs Taken by Millions May be Less Safe than Currently Believed, Reports BMJ

    A class of diabetes drug taken by millions of patients around the world may be considerably more dangerous than originally though, owing to the reticence of pharmaceutical companies to share data and make public the results of some of their studies, claim investigators with the British Medical Journal . Background The class of drugs, known as glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors, have already been the subject of ongoing ...
  • Researchers Launch Campaign Calling for Clinical Data Transparency

    • 30 October 2012
    The British Medical Journal (BMJ) has launched a new regulatory-focused initiative it hopes will spur EU regulators to mandate the public release of data generated during the course of clinical investigations into healthcare products. In a series of articles released in its 29 October 2012 issue, the BMJ said it was joining with a host of other data transparency campaigners, including author Ben Goldacre and the editors of several prestigious medical journals in th...
  • Sport Products Focus of MHRA, Academic Investigations

    It hasn't been a particularly good week food and supplement manufacturers, and in particular those of the sport science variety. In a widely-covered study published in the British Medical Journal, lead-author Carl Heneghan and ten of his colleagues set about trying to determine what evidence, if any, substantiated claims by sports drink manufacturers that their products enhanced athletic performance. The results were not flattering for the manufacturers of the 104 p...
  • UK Organizations Band Together to Form New Clinical Trial Transparency Standards

    • 24 May 2012
    A number of prominent UK healthcare organizations have banded together to form a new set of principles meant to set a new voluntary standard for the reporting of clinical trial data, reports PMLiVE . The coalition of groups, which includes the Association of the British Pharmaceutical Industry (ABPI), the General Medical Council, the Prescription Medicines Code of Practice Authority and The Academy of Medical Royal Colleges, is being called the Ethical Standards in He...
  • FDA Disputes Study Findings, Goes After Some Clinical Trial Sponsors

    Months after the British Medical Journal ( BMJ ) reported that the US Food and Drug Administration's (FDA) oversight of its clinical trials database was suffering from serious lapses in clinical trial reporting and transparency , US regulators are firing back, charging that the studies' authors "overstated non-compliance with data reporting laws," reports Nature . The studies published in BMJ found some troubling occurrences, including a 78% non-compliance rate wit...
  • BMJ: Despite Warning, FDA Approved Higher-Dose Aricept

    An article in The British Medical Journal ( BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times . FDA review staff noted their concerns about the drug's safety and efficacy, according to  The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding...
  • Study: Poor Health Literacy Detrimental to Patient Health Outcomes

    A new study in the British Medical Journal has found that limited health literacy was associated with higher rates of death among study participants. The study tracked nearly 8,000 patients over the age of 52, and sought to understand the effects of health literacy on patient health. To do this, the study asked patients to read the label of a medicine bottle and answer four simple questions, such as the maximum number of days a medicine may be taken and situations req...
  • BMJ: Patients in US, UK Unknowingly Exposed to Toxic Substances

    The fallout over metal-on-metal hips distributed in the US and UK continues as a new article in the British Medical Journal alleges that hundreds of thousands of patients have been exposed to toxic substances as a result of being implanted with the devices. "Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment," write...
  • BMJ: Lack of Research Transparency Breaks Regulations, Hurts Patients

    A series of studies published this week in the British Medical Journal by groups of researchers from various universities have found serious lapses in clinical trial reporting and transparency . Among the findings: A study led by Andrew Prayle of Nottingham University found that only 22% of trials registered at ClinicalTrials.gov had reported their results in the mandatory one-year post-trial time frame; A study conducted by researchers at the Yale School of M...