RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    EMA addresses use of registry-based studies

    The European Medicines Agency (EMA) has issued a new guideline on registry-based studies, giving detailed advice for use of patient registries in both the pre- and post-authorization phases for medicinal products.    After committee approval and a consultation period with the EU Regulatory Network, the guideline has been released for public consultation, with comments due before the end of 2020.   The guideline’s focus is on the use of patient registries for studie...
  • Regulatory NewsRegulatory News

    FDA finalizes ASCA pilot guidance as it gears up for launch

    The US Food and Drug Administration (FDA) on Thursday issued three final guidances on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.   The program, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV), is meant to increase “consistency, predictability and efficiency” during the premarket review of medical devices by creating a scheme for accrediting third party testing laboratories to eligible con...
  • Regulatory NewsRegulatory News

    FDA issues proposed rule clarifying stance on intended use

    After delaying implementation of parts of its final rule on intended uses multiple times, the US Food and Drug Administration (FDA) on Tuesday proposed a new rule clarifying its position on the types of evidence it will consider when determining a product’s intended use. The new rule would also repeal and replace the unimplemented portions of the earlier final rule.   The saga to update FDA’s intended use regulations began in 2015, when the agency first issued a propos...
  • Feature ArticlesFeature Articles

    Manufacturer obligations applying to importers, distributors, or others under MDR and IVDR

    This article discusses issues and requirements spelled out in MDR and IVDR Chapter 2 and that chapter’s Article 16, which applies to manufacturer’s obligations and responsibilities. The author addresses new quality management system (QMS) requirements for repacking and translation of labeling, and the QMS certification obligations. Also covered are cases in which manufacturer obligations apply to importers, distributors, or other persons; changing a device’s intended purpo...
  • Regulatory NewsRegulatory News

    Convergence: Thinking beyond the registry for real-world device evidence

    Medical device registries can provide rich fields for data mining when real-world evidence is sought. But most medical devices will never land on a registry. Does this mean that these manufacturers will not be able to find a source of real-world data?   Not according to Heather Colvin, who spoke during a real world evidence-focused session at RAPS Convergence 2020. Colvin is the director of evidence and outcomes policy for MD regulatory affairs at Johnson & Johnson. Sh...
  • Regulatory NewsRegulatory News

    How to build a professional brand in a virtual world

    CEOs are not the only people who need to worry about their professional branding, attendees of RAPS Convergence 2020 heard during a plenary session. All regulatory professionals should establish a professional brand online and take the time to maintain it.   “How you are perceived is how you succeed,” said Elena Kyria during the 15 September plenary session.   What is a professional brand? It is your professional reputation and it precedes you, surrounds you, and f...
  • Regulatory NewsRegulatory News

    MDR/IVDR update: Experts share what keeps them up at night

    Speaking virtually at RAPS Convergence on Monday, top European medical device and in vitro diagnostic (IVD) experts shared what keeps them up at night as the date of application for both the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approach.   With MDR delayed to May 2021, and with Eudamed’s full rollout and the IVDR date of application seemingly on track for May 2022, regulators, industry and notified bodies have much to prepare...
  • Regulatory NewsRegulatory News

    Voluntary consensus standards guidance updated by FDA

    Voluntary consensus standards guidance updated by FDA   The US Food and Drug Administration has issued a final guidance addressing voluntary consensus standards, updating a September 2018 version.   The final guidance also supersedes one issued in 2007 by the Center for Devices and Radiological Health (CDRH) entitled “CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition.”   The final document, ...
  • Regulatory NewsRegulatory News

    FDA updates Pre-Cert pilot for SaMD

    Lessons learned from a digital health software pilot pre-certification program have readied the US Food and Drug Administration (FDA) to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD).   The precertification (Pre-Cert) pilot “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices,” said FDA in...
  • Regulatory NewsRegulatory News

    MHRA: Post-transition guidance on licensing medicines

    In its suite of post-transition guidances released Tuesday, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.   The guidance, which largely mirrors the “no deal” scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing au...
  • Regulatory NewsRegulatory News

    MHRA posts suite of post-transition guidances

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.   Clinical trials   Two guidances related to clinical trials explain requirements for the registration of clinical trials for investigational medicinal products and the submission of substantial ...
  • Feature ArticlesFeature Articles

    Regulatory Focus, August issue: Global clinical trials, clinical trial applications

    Feature articles during August focused on global clinical trials and clinical trial applications, with articles on regulatory options for conducting clinical trials in China, a case study on the impact of COVID-19 on submissions to European authorities, and an examination of Canada’s application process and alternate pathway for COVID-19‒related trials. Also included was an article on US Food and Drug Administration (FDA) updates on requirement for EUAs for diagnostics sup...