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  • Regulatory NewsRegulatory News

    FDA, EMA officials discuss impediments to cell and gene therapies

    The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a  “playbook” or platform approach for developing multiple cell and gene therapy products and a globally harmonized template would facilitate the development of such products at a 17 May meeting of the American Society of Gene and Cell Therapy (ASGCT).   Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER) and Ana Hidalgo-Simon, head of advanced t...
  • Regulatory NewsRegulatory News

    Study: Novel drug approvals in 2020 continue trend of fewer preapproval pivotal trials, surrogate endpoints

    More than half of the novel drugs approved by the US Food and Drug Administration (FDA) in 2020 were supported by a single pivotal trial, and slightly less than half of pivotal trials supporting novel drug approval used surrogate endpoints as a primary outcome, according to new research published in JAMA Network Open .   The use of fewer pivotal trials and acceptance of surrogate endpoints is the continuation of a trend with the development of new regulatory pathways ...
  • Regulatory NewsRegulatory News

    FDA works to advance real-world data collection in pregnancy and lactation

    The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety and efficacy of medications used during pregnancy and lactation.   Despite the widespread use of prescription and over-the-counter medications by pregnant and lactating women, there is often little or incomplete information to guide decisions about starting and stopping medications or changing doses.   “Although the lack of s...
  • Regulatory NewsRegulatory News

    IVDR: Commission adds risk management standard to harmonized standards list

    The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).   The Commission has now officially added the international risk management standard EN ISO 14971:2019 to its reference list, as well as an amendment to the standard, EN ISO 14971:2019/A11:2021.   In total, the Commission has recogniz...
  • This Week at FDAThis Week at FDA
    Regulatory NewsRegulatory News

    This Week at FDA: House holds user fee markup, CDER’s ARC for rare diseases

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we saw legislation to reauthorize the FDA’s user fee programs advance in the House. We also learned that FDA is standing up a new program to speed the development of treatments for rare diseases with unmet medical need. Plus, we take a look at a new GAO report on FDA’s efforts ...
  • Regulatory NewsRegulatory News

    Euro Convergence: Attendees want end to regulatory ‘micromanagement’

    Corrected 13 May 2022* AMSTERDAM – Regulatory professionals have a big ask for regulators and other health authorities: Trust us.   Gathered at RAPS Euro Convergence at a panel on how to better communicate with health authorities and notified bodies, they voiced their displeasure and asked for a respite from what they describe as micromanagement.   “You heard from academia, you heard from the early start-ups, you heard from the large manufacturers [at this confe...
  • Regulatory NewsRegulatory News

    Pandemic highlighted challenges of ATMP clinical trials in Europe

    AMSTERDAM - A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19 pandemic, Charlie Mortazavi said here at RAPS Euro Convergence.   That attention and future clarification of the regulations could help clear the way for clinical trials of advanced therapy medicinal products (ATMP) in Europe, said Mortazavi, senior manager of global regulatory affairs a...
  • Regulatory NewsRegulatory News

    FDA offers insight into product quality assessment principles

    The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications (NDA), biologics license applications (BLAs), and supplements.   The draft guidance , released on 10 May, provides details on possible mitigation strategies for quality issues and the circumstances under which unresolved quality issues could be addressed during a public health emergency or wides...
  • Regulatory NewsRegulatory News

    Euro Convergence: AI, notified body shortage top health authorities session

    AMSTERDAM – European healthcare product regulators should begin to focus on harmonizing guidance on artificial intelligence/machine learning (AI/ML) across regulatory regimes, according to a panel of health authority representatives at a townhall meeting at the 2022 RAPS Euro Convergence.   On 11 May, a high-level group of representatives from health authorities, notified bodies, and regulatory agencies opened themselves up for questions from delegates who asked them a...
  • Regulatory NewsRegulatory News

    Changes to pediatric, orphan drug regulations on European horizon

    AMSTERDAM - As regulators craft revisions to the European regulations governing pediatric and orphan drug development, the time is now for stakeholders to gather their thoughts and prepare their comments aimed at improving the impending draft documents.   That was the message that Karl-Heinz Huemer of the scientific office at the Austrian Medicines Agency (AGES) brought to delegates at RAPS Euro Convergence.   The European Paediatric Regulation 1901/2006 and amen...
  • Regulatory NewsRegulatory News

    Euro Convergence: Big data offers the potential to improve patient outcomes

    AMSTERDAM – Regulatory experts speaking at the opening plenary of RAPS 2022 Euro Convergence on 10 May discussed the potential to improve patient outcomes by harnessing the power of registries and other large databases, including Eudamed and the recently proposed European Health Data Space (EHDS).   Data, sharing and outcomes   Alan Fraser, chair of the Regulatory Affairs Committee of the Biomedical Alliance in Europe and a consultant cardiologist at the University...
  • Regulatory NewsRegulatory News

    Posters highlight research, regulatory updates at Euro Convergence 2022

    This year’s RAPS Euro Convergence features research and updates on the use of new technology and regulatory tools as part of the conference’s poster session.   Featured posters include an analysis of the regulatory challenges for products with artificial intelligence/machine learning, the best use of regulatory intelligence and automation, evolution in medical device labeling technology, implications of reforms to China’s National Medical Products Administration (NMPA)...