• ReconRecon

    Recon: ASCO 21 updates; Moderna goes for teen EUA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization ( NYT ) ( NPR ) President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals ( Fortune ) Bipartisan Legislation Introduced to Advance Biomedical Research Stalled by Pandemic ( Global Genes ) ...
  • Feature ArticlesFeature Articles

    Strategic lifecycle approach to medical device regulation

    The purpose of this article is to highlight new facets of EU Medical Device Regulation (MDR) in the medical device industry. The article contains references to both MDR legal articles and recommendations that will challenge organizations to take a more holistic viewpoint of their products, resources, and regulatory toolkit to be compliant in the EU.   Introduction The application date of 2017/745 MDR 1 is 26 May 2021, when it will officially supersede the 93/42/EC...
  • Regulatory NewsRegulatory News

    EMA recommends bluebird bio's Skysona, seven other medicines

    The European Medicines Agency (EMA) issued a favorable opinion for bluebird bio’s Skysona (elivaldogene autotemcel), a gene therapy that treats early cerebral adrenoleukodystrophy (CALD). Seven other medicines also received positive recommendations from the agency’s Committee for Medicinal Products for Human Use (CHMP) during its May meeting.   Skysona’s status as an advanced therapy medicinal product (ATMP) means it was first assessed by EMA’s Committee for Advanced T...
  • ReconRecon

    Recon: NGM's NASH drug fails; Alzheimer's breakthrough?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Covid cases hit lowest level since June ( CNBC ) ( NPR ) Scott Gottlieb says vaccinations are not the only factor driving U.S. Covid cases down ( CNBC ) Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health (Harvard Law blog ) Covid vaccine passports: Everything we know so far ( CNBC ) White House says no plans to require vacci...
  • Regulatory NewsRegulatory News

    MDCG offers guidance on clinical investigations in Eudamed’s absence

    The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance providing a set of templates that will be used to fulfill the application/notification submission requirements for clinical investigations under the Medical Device Regulation (MDR) prior to the availability of the Eudamed clinical investigations and performance studies module.   Under MDR, sponsors of clinical investigations for medical devices are required to submit an appli...
  • RoundupsRoundups

    Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

    The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.   Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisd...
  • Regulatory NewsRegulatory News

    MDCG prods COVID diagnostic makers to assess variants

    The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests.   “The notice underlines the manufacturers’ responsibilities to continually assess the impact of newly identified genetic variants of SARS-CoV-2 on the capability of those IVDs to meet their performance, r...
  • RoundupsRoundups

    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...
  • Feature ArticlesFeature Articles

    EU MDR countdown: Readiness of medtech companies in Europe

    Around 75 days before the EU Medical Device Regulation’s May 2021 deadline, a survey was launched to evaluate EU-based medtech companies’ readiness for the impending changes. The findings showed that many manufacturers, particularly those with lower-risk devices, still feel unprepared for the new demands a year after the postponement. Notified bodies no longer seem to pose a major challenge, yet the regulation remains time- and cost-consuming, especially with regard to cli...
  • Regulatory NewsRegulatory News

    Euro Convergence: EU pediatric medicines regulatory framework needs simplification, optimization

    Industry would like to see some “pragmatic” changes to the regulatory process for pediatric medicines in the EU, according to a recent presentation at RAPS Euro Convergence 2021.   These changes include incorporating scientific discussion throughout a product’s life cycle, comparable reporting requirements for pediatric trials to those for adult trials, and optimization and simplification of pediatric investigation plan (PIP) procedures and compliance checks, said Thom...
  • Regulatory NewsRegulatory News

    Euro Convergence: Market access pathways for AI now visible

    The pathways companies will use to bring artificial intelligence or machine learning (AI/ML) medical devices and diagnostics to market in the future are now becoming clear, Loganathan Kumarasamy, head of US compliance services at Zifo Technologies, said at RAPS Euro Convergence 2021.   Devices and diagnostics that make use of AI and ML need regulation specific to the field, Kumarasamy said, pointing out that software in medical devices has long been used safely under e...
  • Regulatory NewsRegulatory News

    Euro Convergence Day 3: AI's regulatory framework, the future of ATMPs, and more

    As Euro Convergence 2021 draws to a close, the European regulatory affairs community will gather virtually to hear updates on artificial intelligence and cell and gene therapies, and to explore how post-marketing surveillance will change in the upcoming years.   Use of artificial intelligence (AI) is seeping into more and more corners of healthcare, and those working in medical devices need to know how regulators address these technologies. Pat Baird, a senior regulato...