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    Additive/3D Printing Manufacturing: Regulatory Concerns

    This article discusses “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. It draws much of its material from a new US FDA Guidance document that discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety. Introduction The term ...
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    FDA Releases Novel Technical Framework for 3D Printed Medical Devices

    This article discusses the value, potential and challenges of using 3D printing (Additive Manufacturing (AM)) to develop products for use in the pharmaceutical industry. The author reviews the US Food and Drug Administration’s (FDA’s) guidance on AM in terms of design as well as manufacturing and device testing considerations. Emphasis is placed on the evolutionary aspects of providing final guidance on 3D printed products as well as the need for manufacturers using AM to...
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    Emerging Technology Integration in FDA’s Drug Approval Process

    This article discusses important aspects of the US Food and Drug Administration’s (FDA’s) “Emerging Technology Program” with a focus on emerging technology, such as continuous manufacturing and 3D printing, and details what information is to be included in drug submissions. The authors highlight a number of benefits of the program, including the synergy created between FDA and the pharmaceutical industry. Introduction An important step in FDA’s mission to support pharma...
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    Regulatory Challenges for Artificial Intelligence Applications in Healthcare

    This article addresses regulatory challenges associated with using artificial intelligence in healthcare. The authors explore challenges in regulating “digital health” and review various pathways to gain regulatory approval for artificial intelligence applications to be employed in healthcare. They recommend potential approaches for resolving regulatory challenges that may arise with the use of new technologies and discuss the variety of FDA initiatives aimed at helping t...
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    Unifying the Clinical Landscape to Drive Efficiency and Compliance

    This interview with Terry Murphy, Vice President of Janssen Research and Development, describes problems experienced with the company’s critical technologies for conducting global clinical trials, how the decision was made to replace them and what new technologies were implemented. Murphy reviews the benefits gained after the replacement was completed and also explains how the company maintains data security while they are “watching the marketplace and the evolution of te...
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    Drug Reform, Expedited Pathways, Regenerative Medicine and Gene Therapy

    Articles posted throughout May included global opportunities and requirements for expedited pathways, a harmonized gene therapy model, drug shortage roadmap for the temporary importation of a prescription pharmaceutical and regenerative medicine policy framework. Other articles covered global regulatory timelines for drug applications and regulatory reform, the impact of FDA's change in policy on voting pattern and MHRA's Promising Innovative Medicines (PIM) designation a...
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    Accelerated Pathways in the US and EU for Expedited Marketing Authorization Approval

    This article provides a high-level overview of the available accelerated pathways and key differences, along with a case study discussion on Tagrisso™ (osimertinib, AstraZeneca, LLP). The authors primarily focus on the sponsor's journey taking Tagrisso through the accelerated pathways in US and EU to deliver one of the fastest drug development timelines.  Introduction Drug development traditionally involves long clinical trials and exposes thousands or tens-of-thousands...
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    Brazilian Regulatory Timelines for Drug Applications

    This article discusses changes to Brazilian law regarding its pharmaceutical industry allowing the Brazilian Health Regulatory Agency to overhaul and improve regulatory processes, streamline the time to drug approval and impact the public's health and welfare. Introduction The global pharmaceutical industry considers Brazil a promising market. In 2015, Brazil was ranked 7th among global pharmaceutical markets and estimates indicate the nation's potential to become the w...
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    China Regulatory Reform: An Update on Review Timelines and Drug Lag

    This article provides three case studies with an assessment of the impact of the regulatory changes and insight into the importance of including China in a global strategy for clinical development and drug registration. Introduction China has implemented a series of regulatory changes and improvements through a comprehensive regulatory reform starting in August 2015. The largely shortened new drug review timeline provides one of the biggest impacts for the pharmaceuti...
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    Japan's Conditional Approval Pathway for Regenerative Medicines

    This article discusses the history, reasoning, legal decisions and subsequent regulatory requirements behind Japan's bid to become a world leader in regenerative medicine. The authors outline the process for seeking new regenerative product approvals through an accelerated regulatory pathway and spell out the oversight role played by Japan's regulatory authorities to enable new regenerative, cell-based therapies to be made available to the public in Japan as soon as possi...
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    Regenerative Medicine Advanced Therapy Designations

    This article discusses recent legislative action regarding Regenerative Medicine Advanced Therapies (RMAT). The author describes the criteria RMAT candidate treatments must meet to apply for RMAT designation from the US Food and Drug Administration (FDA) and outlines the steps applicants must take to gain RMAT designation from FDA. She compares the processes and success rates for applying for and gaining RMAT designation to the processes and success rates for gaining "bre...
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    Providing Early Access to Innovative Medicines in the UK

    This article discusses the variety of steps and agencies involved in providing patients in the UK with serious and/or life-threatening illness early access to promising innovative medicines. The author reviews and spells out how designations to Promising Innovation Medicines (PIM) are gained and the schemes under which early access may be granted. Introduction In February 2018, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release an...