• Regulatory NewsRegulatory News

    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
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    Clinical trial site remote monitoring may suffice: Updated FDA guidance

      Remote monitoring to oversee clinical trials has been one of the flexibilities the US Food and Drug Agency (FDA) has, in some cases, permitted during the COVID-19 pandemic. Now that some pandemic-related restrictions are lifted, though, does remotely obtained site information “count,” or do these sites need to be re-monitored in person?   To respond to this knowledge gap, a new question and accompanying answer (Q and A) have been appended to the final guidance docu...
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    Groups suggest changes to FDA’s guidance expanding eligibility criteria for oncology trials

    While groups expressed overwhelming support for the US Food and Drug Administration’s (FDA’s) draft guidance expanding eligibility criteria for investigational oncology trials, some comments discouraged the agency from taking an approach that dichotomizes the curative and non-curative setting; a pharmaceutical firm suggested that safety data be combined for some investigations performed in curative and non-curative settings.   Among the recommendations of the draft gu...
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    Working group: More guidance needed on MRD in myeloma trials

    A working group formed to consider the use of minimal residual disease (MRD) in the treatment of multiple myeloma and the development of new therapies has issued a call for additional regulatory guidance on the use of MRD as a marker in clinical trials.   The working group, a collaboration of advocacy organizations, patients, research foundations, academic, government agencies and industry, was initially convened in 2016 by the Foundation for the National Institutes of...
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    CTIS set to launch in EU; sponsor guide now online

    The European Commission (EC) has affirmed that it plans to launch the Clinical Trials Information System by the end of January 2022, as part of its broader efforts to modernize and streamline the conduct and oversight of clinical trials in the EU.   “The pandemic has clearly shown the importance of efficient clinical trials that do not compromise on rigorous safety and efficacy standards,” said Stella Kyriakides, EC commissioner for health and food safety, speaking o...
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    Another drug firm faces potential fines for research non-reporting

    A small Georgia pharmaceutical company has received a notice of noncompliance from the US Food and Drug Administration (FDA) for not registering clinical trial results in a central government registry, as required by federal law.   The 26 July letter is the second issued by FDA for noncompliance with federal research reporting requirements outlined in Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). If results are not reported within on...
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    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...
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    MHRA announces streamlined clinical trial review process

    In the wake of the systemic changes flowing from the UK’s exit from the EU, the country’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline review of clinical trials for medicinal products.   Beginning in January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will receive a combined review from MHRA and the UK Research Ethics Services, with collaboration from the UK’s Health Research Authority (HRA). The process is...
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    FDA finalizes guidance on studying CNS metastases in cancer trials

    A final guidance document from the US Food and Drug Association (FDA) provides recommendations for drug developers on how best to evaluate the safety and efficacy of cancer drugs in patients with central nervous system (CNS) metastases. The document finalizes a draft guidance issued in August 2020.   "There are few effective treatments for patients with central nervous system (CNS) metastases – a type of cancer that has spread from the original tumor to the CNS and is ...
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    The transition to ICH M10 and its impact on global submissions

    With the expanding globalization of drug development, regulations put forth under the International Council for Harmonisation’s (ICH’s) M10 guidance support the transition to a more harmonized industry. The draft guidance marks another step of integrating international expectations, in this case, as it applies to bioanalytical evaluations. This article examines the key elements of the M10 standard and recommends strategies for successful new drug or clinical trial applicat...
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    Acceleron, under threat of fines, reports out a negative study

    The day after receiving a first-ever threat of civil penalties for failure to report clinical trial results to ClinicalTrials.gov, Acceleron Pharma fulfilled a legal mandate by posting summary results to the federal trials website.   Though the negative results for its trial of dalantercept and axitinib in patients with advanced renal cell carcinoma had been published elsewhere years earlier, Massachusetts-based Acceleron had not previously complied with federal report...
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    FDA updates guidance on covariate treatment in clinical trials

    In a revised draft guidance, the US Food and Drug Administration (FDA) has clarified how drug developers should adjust for covariates in certain clinical trials.   The revision provides “more detailed recommendations for the use of linear models for covariate adjustment and also includes recommendations for covariate adjustment using nonlinear models,” according to FDA’s Federal Register notice of the newly revised draft.   The updates to the April 2019 draft l...