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    When Can Drugmakers Cite Quality Standards From Foreign Compendia? FDA Explains

    An updated Manual of Policies and Procedures (MAPP) for the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lays out when drug sponsors and applicants can propose specifications for excipients, drug substances and drug products in their applications based on quality standards in the British Pharmacopoeia (BP), the European Pharmacopoeia (EP) or the Japanese Pharmacopoeia (JP). Updated from 2007 and 2014 versions, the MAPP says that such ci...
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    European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Maps International Regulatory Coordination Initiatives to Show Overlaps, Gaps The European Medicines Agency (EMA) has mapped cooperative regulatory initiatives to better understand how and where international peers are working together. EMA found there were a “myriad of initiatives but no strategic coordination,” prompting it to warn regulators are duplicating effo...
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    Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia . CFDA Posts Draft Medical Device Adverse Event Monitoring Guidance China’s Food and Drug Administration (CFDA) has posted draft guidance on post-marketing supervision of medical devices. The guidance sets out the role regional and national regulators, medical device manufacturers and adverse event monitoring technology institutions will play in tracking the safety of...
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    HHS Inspector General Calls on CMS to Incorporate UDIs Into Claims Forms

    In a letter to the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt on Friday, Department of Health and Human Services (HHS) Inspector General Daniel Levinson calls on CMS to work with the Accredited Standards Committee (ASC) X12 to incorporate unique device identifiers (UDIs) for implantable devices into insurance claims forms. According to Levinson, doing so could help CMS keep track of the costs associated with recalled and defective me...
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    The Path Less Followed - Submission Guidance for Responsive Design Websites

    This article recommends an operational path forward for streamlining the development and review of "responsive design" websites for pharmaceutical products promotion. Introduction It is no secret. The Internet has become the first stop for adults seeking health-related information. 1 At the beginning of the Internet revolution, prospective patients were limited to getting their information on desktop terminals.  As Internet accessibility expanded into mobile devices,...
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    FDA’s CBER to Forge Stronger Ties With WHO

    The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards. FDA's Center for Biologics Evaluation and Research (CBER) anticipates providing up to $2 million in FY 2016 to support the project, as w...
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    Generic Topical Patches: FDA Offers Draft Guidance on Adhesion Studies

    Generic drugmakers submitting clinical studies on the adhesive performance of a transdermal delivery system (TDS) or topical patch will want to take note of new draft guidance released Tuesday from the US Food and Drug Administration (FDA). This guidance describes the recommended approach to an adhesion clinical study design used to support an abbreviated new drug application (ANDA) and, once finalized, the guidance will supersede FDA’s prior recommendations related to a...
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    European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

    In the Official Journal of the European Union, the European Commission on Friday published a new list of the harmonized standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law. The standards were published as part of the implementation of the European Council’s Directive 93/42/EEC from 1993, which deals with medical devices and their regulation. Background ...
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    FDA Amends Regulations on General Biologic Standards for First Time Since 1977

    The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities. Issued directly as a final rule – because FDA says it believes the updates include “only noncontroversial amendments” and FDA anticipates no major objections from industry – the new regulations are part of FDA’s continuing effort to...
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    Practical Guidance for Regulatory Professionals on Combination Products

    This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities. Combination Products Combining a drug, device or biological product into a new product (frequently called a "combination product") continues to be an important and growing category of therapeutic products. Approximately one-thir...
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    Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards

    Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics. Kicking off a two-day public workshop today, FDA Commissioner nominee Robert Califf said that NGS tests hold great promise for patients, but still present "tremendous uncertainty." The issue, he said, is determining "how accurate [and] how useful can we make the predictions that come from these tests." Califf als...
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    FDA Guidance Outlines Principles for Adaptive Design in Device Clinical Trials

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. New draft guidance from the US Food and Drug Administration (FDA) lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity. Known as  adaptive design , the method can minimize clinical trial sponsors’ resou...