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    EC: 3 More Notified Bodies to be Designated Soon

    The European Commission (EC) said three additional notified bodies are awaiting publication in the Nando database as designated under the Medical Devices Regulation (MDR), according to an update. Currently, nine NBs have been designated , including three from the Netherlands, four from Germany, one from Italy and one from the UK. The slow progress has experts concerned that there will not be enough NBs designated by the MDR’s date application on 26 May, which could l...
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    Initial Golodirsen CRL Raises Alarms Over Eteplirsen Confirmatory Study

    As part of the US Food and Drug Administration’s (FDA) approval package for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) injection Vyondys 53 (golodirsen) last month, the agency on Wednesday raised questions about a confirmatory trial for another approval in the golodirsen complete response letter (CRL) from last August. The letter, which typically remains confidential unless a company later wins approval, raises concerns about both golodirsen and Sarepta’s p...
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    EU Court of Justice Rules in Favor of EMA in Transparency Case

    The Court of Justice of the EU on Wednesday ruled that the European Medicines Agency (EMA) acted lawfully when it released certain toxicology reports and a clinical study report from two sponsors that wanted to keep that information confidential. The cases centered around New Jersey-based PTC Therapeutics and MSD Animal Health (part of Merck), which claimed that EMA’s disclosure of a clinical study report, in the case of PTC, and five toxicology reports from MSD Animal ...
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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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    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...
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    FDA to Allow Online Submissions of Orphan Designation Requests

    As part of work building on the US Food and Drug Administration’s (FDA) orphan drug modernization plan from 2017 , the agency said Friday that later this year it will move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests. The shift to online submissions will ease the process of making orphan drug designation requests, which are currently  mailed into the Office of Orphan Products Development (OOPD) on a CD. ...
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    MAPP Further Explains FDA Process for Reviewing REMS Assessment Reports

    The US Food and Drug Administration (FDA) last month offered a new Manual of Policies and Procedures (MAPP) to explain how the Center for Drug Evaluation and Research (CDER) reviews risk evaluation and mitigation strategy (REMS) assessment reports submitted to the agency. Although the statute does not specifically describe how companies should conduct their assessments, the agency has released two draft guidances (one on survey methodologies and another on planning and ...
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    'CurAll' or 'Bestmab': FDA to Study How Proprietary Names Affect Perceptions

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is planning a study to investigate how proprietary drug names affect consumers’ and/or healthcare providers’ perceptions and whether they might overstate the efficacy of a drug. During FDA’s prescription drug approval process, sponsors propose proprietary names for their products, which are reviewed by the Office of Drug Safety, the relevant medical office and OPDP. OPDP reviews nam...
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    Clinical Decision Support Software: Stakeholders Seek More Clarity From FDA Draft Guidance

    Industry groups, the Mayo Clinic, Regeneron and others are seeking more clarity from the US Food and Drug Administration’s (FDA) revised draft guidance on clinical decision support (CDS) software. The 27-page draft from September builds on a previous draft from 2017, with which industry also raised concerns . The latest draft clarifies the categories of CDS software subject to FDA oversight, as well as the low-risk categories of CDS software for which FDA does not in...