• Regulatory NewsRegulatory News

    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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    EMA Consults on GMP Reflection Paper

    The European Medicines Agency (EMA) this week released a draft reflection paper for consultation outlining the good manufacturing practice (GMP) responsibilities applicable to marketing authorization holders (MAHs) under European Commission (EC) GMP guidelines and other EU legislation.   The aim of the 31-page reflection paper is to clarify the myriad GMP responsibilities for MAHs, which EMA admits “can, in some cases, be difficult to comprehend when reading the GMP gu...
  • TrackersTrackers

    The Essential List of Regulatory Authorities in Europe

    To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list is organized by regional affiliation with the European Union (EU), European Free Trade Association (EFTA) and other European countries. For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the informatio...
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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...
  • ReconRecon

    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 prices newly approved thyroid eye disease therapy at $14,900 per vial ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) Johnson & Johnson beats Wall Street expectations on profit, misses on revenue ( CNBC ) California considers declaring common pain killer carcinogen ( AP ) Ex-drug execs get over 2 years in prison for bribery scheme ( AP ) ( Law360 -$) Suns...
  • Feature ArticlesFeature Articles

    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...