• 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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,...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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. ...
  • Regulatory NewsRegulatory News

    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...