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    Australia Considers Allowing the Marketing of Devices Approved Overseas

    Australia’s Therapeutic Goods Administration (TGA) on Monday released a proposal to allow for the use of devices that have received marketing approvals from select foreign authorities. TGA says its primary objective in releasing the proposal is to either: Use approvals from comparable overseas regulators as the evidence of regulatory compliance for including devices in the Australian Register of Therapeutic Goods (ARTG) (and to avoid the need for duplicate assessments...
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    FDA Officials Discuss Modernizing the Regulation of Combo Products

    As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature . Nina Hunter, FDA’s associate director for science policy, and Rachel Sherman, F...
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    Impact of the Revised EU Clinical Trial Regulation

    Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulat...
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    GAO Survey of State Regulation of Drug Compounding Offers Mixed Results

    Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use. Building on a 2016 report , the new survey  results released by the US Government Accountability Office on Friday on the state regulatio...
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    Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes

    A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations. Background Pediatric study requirements are included in both the Pediatric Research Equity Act (PREA), which requires biopharma companies to ...
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    MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU

    The following article represents the views and interpretations of the author and do not necessarily reflect those of RAPS: This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR. Introduction Both the MDR: the EU Medical Device Regulation, 2012/0266 (COD) and ...
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    CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics

    The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children. According to CTTI, a public-private partnership aimed at improving the quality and efficacy of clinical trials, challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations. Furthermore, ...
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    ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success

    France's Agency Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on Wednesday reported positive results for its year-long pilot for assessing clinical trials using the process established in the new EU Clinical Trials Regulation . Background In 2014, Regulation (EU) No. 536/2014 , known as the new Clinical Trials Regulation , was adopted. The goal of the regulation is to provide faster, more coordinated assessments for clinical trial applications t...
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    International Generic Drug Regulators Outline Plans for Collaboration Through 2020

    As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years. Strategic priorities for the consortium include establishing a framework for sharing assessment-related information between regulators, promoting convergence of technical and data requirements and increasing the alignment of administrative and regula...
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    European Commission Clears up Questions on Orphan Drug Regulation

    Following a public consultation in November 2015, the European Commission (EC) has released a new communication intended to clarify some lingering questions about the EU's Orphan Regulation . The consultation sought to address five issues that have arisen since the Orphan Regulation came into effect in January 2000: Clarifying the meaning of "significant benefit" How to apply the Orphan Regulation to emerging diseases, such as Ebola, that are not present within...
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    FDA Officials Call for Including Adolescents in Adult Oncology Trials

    A team of officials at the US Food and Drug Administration (FDA) are calling for a "culture shift" by drugmakers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials. The officials made the call in a recent article in Clinical Cancer Research , where they argue that excluding older adolescents, ages 12 to 17, from adult oncology trials leads to delayed access to new treatments for those pa...
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    FDA Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance

    The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials. The addendum, E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population , is intended to supplement ICH's E11 guidance by expanding  the discussion on issues related to pediatric clinical trials in light of scientific and regulatory ...