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    IMDRF Works to Speed Entry of Devices Across Multiple Countries

    The International Medical Device Regulators Forum (IMDRF) proposed updates on Wednesday to clinical evaluation documents in support of rapid market entry across multiple jurisdictions. The IMDRF’s medical devices clinical evidence working group (MDCE WG) re-issued consultations Wednesday to propose updates to three Global Harmonization Task Force (GHTF) documents from 2007 and 2010. The MDCE WG’s consultation documents seek to reflect the recently implemented and/or ...
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    HMA Offers Recommendations on Complex Clinical Trials

    A subgroup of the EU’s Heads of Medicines Agencies (HMA) issued new recommendations Friday on conducting complex clinical trials.   The HMA’s Clinical Trials Facilitation Group (CTFG)—coordinated by the Danish Medicines Agency—identified eight key recommendations to establish a framework on the initiation and conduct of complex trials for the development of personalized medicine. They were prepared “in recognition of the fact that the development of personalized medici...
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    FDA Alerts on Increased Risks Linked to Pfizer’s Xeljanz

    The US Food and Drug Administration (FDA) alerted the public late Monday of a post-marketing safety clinical trial for Xeljanz (tofacitinib) that found an increased risk of lung blood clots and death in patients with rheumatoid arthritis (RA) who were taking a dose of 10 mg twice daily. The drug safety communication noted the increased risk was observed in the post-marketing trial set as a requirement on Pfizer following the first approval  of Xeljanz in 2012. It comes...
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    UK Seeks to Increase Clinical Trials Transparency

    The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018. “Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report . “Only with a system which values transpar...
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    FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder

    The US Food and Drug Administration (FDA) issued draft guidance on Wednesday to aid sponsors in the clinical development of drugs and biologics for the treatment of eosinophilic esophagitis (EoE). The 13-page draft guidance document describes the agency’s clinical trial recommendations for EoE drugs. These relate to trial population and design, safety and efficacy considerations, clinical outcomes assessments, as well as pediatric considerations. The clinical developmen...
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    Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds

    The rare pediatric priority review voucher (PRV) program was not found to be associated with an increase in the number or rate of new rare pediatric disease drugs that began clinical trials, a Health Affairs study found. But the researchers from Harvard Medical School, working on what they said is the first study on the impact of the rare disease PRV program on drug development, also found that their data do provide some encouraging news about rare pediatric disease d...
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    FDA Leadership Calls for LDT Reforms

    While championing advances made in diagnostic technology in recent years, top officials from the US Food and Drug Administration (FDA) are calling for a new regulatory framework for in vitro clinical tests (IVCTs) and laboratory developed tests (LDTs). The call comes as lawmakers from both parties on Thursday released a new 200-page discussion draft of a bill that would establish such a framework, incorporating many of the reforms FDA has recommended, including a pr...
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    Woodcock Pushes for Major Digital Shift in Regulation

    Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, made clear on Tuesday that there needs to be a major shift in regulatory toward a more digital world. “The time has come that we think about digital tech in a new way to streamline and use the digital age to effectively regulate and efficiently regulate,” Woodcock said at the Friends of Cancer Research annual meeting Tuesday. She noted that regulators arou...
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    France Begins Speeding Clinical Trial Start-Up Times

    As part of a push to more quickly offer patients access to innovative treatments, France’s drug regulator, known as ANSM, has established two “Fast Track” options that will expedite the authorization of clinical trials. Unlike the US Food and Drug Administration’s (FDA) Fast Track process, which is designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need, France’s new designation concerns clinical trials of innovative treatment...
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    EMA Revises Guidance on Publication of Clinical Trials Policy

    The European Medicines Agency on Friday offered a look at the major and minor changes made to guidance on the agency’s policy on the publication of clinical data for medicinal products for human use.   The policy, known as “Policy 0070,” was adopted by the EMA Management Board on 2 October 2014 and is composed of two phases. Phase 1 entered into force on 1 January 2015 and pertains to publication of clinical reports while Phase 2, which will be implemented “at a later ...
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    Drugmakers Seek Clarity on Guidance on Use of Placebo and Blinding in Oncology Trials

    A half-dozen biopharma companies are seeking further clarity from the US Food and Drug Administration (FDA) regarding draft guidance from August on using a placebo in certain oncology trials. The draft features FDA’s thoughts on the ethical challenges of using a placebo in randomized controlled clinical trials for therapies to treat hematologic malignancy and oncologic disease. The draft also discusses blinding and unblinding, patient reported outcomes (PROs) and prac...
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    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...