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  • Regulatory NewsRegulatory News

    EC floats cross-sector health innovation partnership

    In a draft document issued 29 July, the European Commission (EC) unveiled its plan for integration of health technology capabilities across the European Union (EU). The plan was lauded by five pharmaceutical and medical technology associations who signed on to a joint statement welcoming the proposal.   Dubbed the Partnership for Health Innovation, the initiative aims to facilitate translational work by creating an EU-wide “health research and innovation ecosystem,” to...
  • Feature ArticlesFeature Articles

    Regulatory Focus, July issue: Cell and gene therapy

    Feature articles during July focused on global regulatory strategy for cell and gene therapy, with articles on US and EU regulations and guidances and the development and manufacture of the therapies. Also included were articles on recasting the corrective and preventive action (CAPA) process as a continuous improvement process, a military-civilian perspective on real-world evidence (RWE) to support regulatory decision making, and regulatory reporting in multinational tria...
  • Feature ArticlesFeature Articles

    Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

    This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical...
  • Regulatory NewsRegulatory News

    FDA issues final guidance on multiple function device products

    A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions.   The guidance addresses provisions of the 21 st Century Cures Act ( Cures Act) that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new document follows an April 2018 draft guidance and clarifies just how – an...
  • Regulatory NewsRegulatory News

    FDA exempts additional Class II devices from 510(k) requirements

    The US Food and Drug Administration (FDA) on Tuesday finalized an order to exempt five types of Class II medical devices from 510(k) requirements, which the agency says will decrease regulatory burdens on industry for makers of those devices.   Under the 21 st Century Cures Act , FDA was instructed to publish lists of Class I and Class II devices it would exempt from 510(k) requirements at least once every five years. In 2017, FDA exempted more than 70 Class I device...
  • Regulatory NewsRegulatory News

    FDA issues enforcement policy for coronavirus transport media

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance to boost the availability of transport media intended to be used to transport clinical specimens for SARS-CoV-2 assays during the coronavirus disease (COVID-19) pandemic.   The guidance applies to transport media for both molecular and antigen diagnostic tests and covers Class I transport media devices falling under seven different product codes: JSG, JSM, JSL, JSN, LIO, JTW ...
  • Regulatory NewsRegulatory News

    Updates on MDR implementation, transparency; MDCG posts CEAR template

    The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices under the regulation.   The Commission’s Medical Devices Coordination Group (MDCG) also released a template for clinical evaluation assessment reports (CEAR) for notified bodies to document their assessments of clinical evidence for medic...
  • Feature ArticlesFeature Articles

    Regulation of advanced therapy medicinal products in the EU

    This article explains some of the terminology relating to advanced therapy medicinal products (ATMPs), including gene and cell-based therapies, tissue-engineered products, and combined ATMPs. The author explains the key EU regulations and guidance documents for each therapy type and discusses marketing authorization, accelerated regulatory pathways, and market access. He advises companies navigating this complex regulatory environment to engage with the regulatory agencies...
  • Regulatory NewsRegulatory News

    House committee advances bills aimed at orphan exclusivity, generic labeling and continuous manufacturing

    The House Energy and Commerce Committee on Wednesday advanced 17 health-related bills for consideration by the House, several of which have implications for the US Food and Drug Administration’s (FDA) oversight of orphan drugs, imported medical devices and labeling.   (RELATED: House committee discusses bipartisan bills on orphan exclusivity, generic drug labels and more , Regulatory Focus 29 January 2020).   “These bills will expand coverage and access to car...
  • Regulatory NewsRegulatory News

    Euro Regulatory Roundup: EU health committee calls for EMA to get wider remit, more staff to stop shortages

    A key health committee has called for the European Medicines Agency (EMA) to get a wider remit and an increased headcount to prevent shortages of essential medicines. The European Parliament committee made the request in a report that argues EMA should be made the regulatory authority in charge of preventing shortages.   In recent months, multiple Parliament committees have begun considering how to address the emerging problem of medicine shortages. As the group primar...
  • FDA guidance addresses ultrasonic prostate ablation submissions

    A new final guidance from the US Food and Drug Administration (FDA) addresses clinical testing and clinical data collection to support marketing authorizations for high intensity ultrasound systems to ablate prostate tissue.   The agency clarified in the guidance that the scope is limited to clinical investigations that support authorization to market the devices for “general indications of prostate tissue ablation systems,” including those regulated under the PLP...
  • Feature ArticlesFeature Articles

    Update on RMAT designations

    This article discusses the scope and purpose of the special designation for regenerative medicine advanced therapies (RMAT) created by the passage of the 21st Century Cures Act. The authors explain the benefits expected to be realized with RMAT and provide a tally of products receiving the special designation to date and a current count, by year, of products for which RMAT designation has been requested.   Introduction Section 3033 of the 21st Century Cures Act, titl...