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    Updated: FDA Classifies Three Radiology Devices Into Class II

    Editor's note: This article has been updated to reflect the release of an updated guidance related to medical image analyzers. 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. FDA also released an updated version of its 2012 guidanc...
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    Recon: Horizon Prices Newly Approved Tepezza at $14,900 per Vial; GSK Pay-for-Delay Appeal Faces EU Rebuke

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Horizon's prices newly approved thyroid eye disease therapy at $14,900 per vial ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) Johnson & Johnson beats Wall Street expectations on profit, misses on revenue ( CNBC ) California considers declaring common pain killer carcinogen ( AP ) Ex-drug execs get over 2 years in prison for bribery scheme ( AP ) ( Law360 -$) Su...
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    Drug Development Process for Biologics: Regulatory Expectations

    This article discusses various elements involved in “upstream” and “downstream” manufacturing processes for biologic drug development and the importance of their unification. The author elaborates on the complexity and sensitivities inherent in biologics and emphasizes safety considerations. Regulatory expectations for biologics development and approval are highlighted. This article relates specifically to the EU regulatory environment.   Introduction   The develop...
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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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    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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    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...
  • ReconRecon

    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...
  • Feature ArticlesFeature Articles

    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...