• Regulatory NewsRegulatory News

    Survey From CDRH Officials Finds Informed Consent Process Needs Improving

    Informed consent forms (ICFs) may meet the necessary regulatory requirements but are often not written in a way to promote comprehension among clinical trial participants, a new research article from six officials in the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) found. The officials surveyed 399 ICFs from investigational device exemption (IDE) applications for fiscal years 2015 and 2016, finding that overall, the ICFs were...
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    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...
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    Almost Half of All New Drug Approvals in 2018 Relied on One Clinical Trial

    Back in the 1970s and 1980s, the US Food and Drug Administration (FDA) made clear that at least two adequate and well-controlled studies were necessary to establish a new drug’s effectiveness, except in only the rarest of circumstances. Then in 1997, the Food and Drug Administration Modernization Act was passed, and Congress clarified that FDA may consider “data from one adequate and well-controlled clinical investigation and confirmatory evidence” to approve a new dr...
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    Health Canada Implements ICH Guideline on Good Clinical Practice

    Health Canada said Wednesday that it has implemented the International Council for Harmonisation’s (ICH) guideline on good clinical practice, known as E6(R2). While working to eliminate the differences between its own and ICH guidances, Health Canada said that in cases of such discrepancies, Health Canada-implemented ICH guidances should take precedence. The decision to implement the guideline in Canada follows the work of its ICH peer regulatory agencies to implemen...
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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...