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    Transitional Leaders Take Charge as FDA Begins Phase III of OND Reorganization

    The US Food and Drug Administration (FDA) on Tuesday officially began Phase III of its Office of New Drugs (OND) reorganization after a short delay, and several leaders of the new offices took charge in an acting capacity, according to an email from OND Director Peter Stein.   Phase III of the reorganization was initially expected to begin on 13 January but was pushed back due to minor delays last week.   During Phase III, OND will be standing up two new offices,...
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    FDA Classifies Three Radiology Devices Into Class II

    The US Food and Drug Administration (FDA) on Tuesday classified two software-based radiology devices into Class II (special controls) following requests for de novo classification from their sponsors. The agency also reclassified medical image analyzers from Class III to Class II.   Specifically, FDA issued two final orders codifying the generic device type and special controls applicable to Quantitative Insights’ Quant X and Viz.ai’s ContaCT after classifying the de...
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    CDER to Launch Drug Risk Management Board

    Later this month, the US Food and Drug Administration (FDA) will formally launch its Drug Risk Management Board (DRMB) to coordinate safety activities among offices, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said in an email to staff on Tuesday.   Woodcock said the DRMB is a center-level body that will also rapidly analyze and resolve drug safety issues by facilitating decision making across CDER on major clinical and quality-related safety...
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    FDA Warns Chinese Manufacturer of ‘Magic Spray for Pain Relief’

    The US Food and Drug Administration (FDA) released warning letters on Tuesday for China-based over-the-counter (OTC) drugmaker Zhuhai Aofute Medical Technology Co., Colorado-based device firm Vevazz and Dallas-based Curewave Lasers. For Zhuhai Aofute Medical Technology Co., which was placed on import alert last November, the FDA inspectors found the firm lacked identity and strength testing for each batch of its OTC product, “Magic Spray for Pain Relief.” In addition...
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    Recon: GSK Nabs Priority Review for Myeloma Drug; BeiGene Lung Cancer Treatment Hits Goals in Phase III Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GSK advances blood cancer drug to FDA, but rivals threaten ( BioPharmaDive ) ( Endpoints ) ( Press ) Scientists find unexpected anti-cancer activity in range of non-oncology drugs ( Endpoints ) ( Scientific American ) ( Broad ) Pfizer’s big data exec on pharma’s ‘arms race’ to partner with companies like Fitbit, 23AndMe, and others ( STAT ) Will the FDA give t...
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    Asia Regulatory Roundup: TGA Proposes Fee Changes to Offset Increase in Costs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Fee Changes to Offset Increase in Costs   Australia’s Therapeutics Goods Administration (TGA) is planning to raise its fees and charges to offset a forecast AU$7 million ($4.8 million) spending increase. TGA’s preferred option is to increase all fees by 1.95%, an indexation factor calculated by looking at changes in wages and consumer prices.   In th...
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    Regulatory Leadership for a Culture of Quality in the US Medical Device Industry

    This article discusses governance and implementation infrastructure as critical factors in cultivating a culture of quality and building the necessary trust employees may need to help achieve it. The author outlines the critical attributes of a culture of quality, explains how such a culture can be built, the benefits it offers and touches on the roles played by regulatory/quality professionals in leading the effort to build quality.   The Case for Quality   In 201...
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    RAPS' Regipedia, a Wiki Built for Regulatory Pros

    One of RAPS’ newest member-exclusive resources may actually be somewhat familiar to you already. RAPS Regipedia is an online compilation of regulatory terms and definitions originally derived from RAPS’ Acronyms & Definitions guides. For nearly two decades, regulatory professionals have been using Acronyms & Definitions guides to look up all manner of terms related to the regulation of drugs, medical devices, biologics and other healthcare products. RAPS published...
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    EMA, HMA Set 10 Priorities for Big Data

    A report from the European Medicines Agency (EMA) and Heads of Medicines Agencies’ (HMA) joint Big Data Task Force released Monday sets out recommendations to unlock the potential of data in medicines regulation.   “Coupled to rapidly developing technology, big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine, and help to better characterize diseases, treatments and the performance of medicines in individual healthcare systems...
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    House Committee Quizzes FDA on Complex Generic Drugs

    A bipartisan group of House Energy & Commerce Committee leaders last Friday sent a letter to US Food and Drug Administration (FDA) Commissioner Stephen Hahn seeking information on the agency’s efforts to approve complex generic drugs more quickly. The congressmen said they are trying to understand if FDA needs additional authority to improve the approval process for complex generic drugs, which can be more difficult to formulate or manufacture than other generic drugs. ...
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    EU NCAs to Offer Simultaneous Scientific Advice for Drug Developers

    As part of efforts to better align scientific advice across the EU, beginning 1 February, a dozen national competent authorities (NCAs) will participate in a pilot project to allow drug developers to obtain two NCA opinions simultaneously. The multi-national discussions aim to provide two NCA opinions within one application, in addition to earlier opinions, better explanations for possibly conflicting opinions, increased interactions between NCAs and the potential for f...
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    OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show

    As the spotlight on foreign drug and medical device facilities brightens because of impurity concerns and a lack of US Food and Drug Administration (FDA) staff abroad, the total number of Official Action Indicated (OAI) classifications continued to fall in 2019, and US-based facilities still saw the lion’s share. A look into FDA’s inspection classification database for the drug, device and biologic centers reveals how China and India’s share of the overall OAI classif...