• RF Quarterly

    Change control in the artificial intelligence era

    Artificial intelligence as medical devices (AIaMDs) have the power to learn from real-world performance and over time and may provide a different output compared with that initially cleared for a given set of inputs. However, regulatory frameworks have remained relatively unchanged and are largely focused on approaches around traditional hardware-based medical devices. In this article, the authors explain the US Food and Drug Administration’s (FDA’s) current thinking on en...
  • Regulatory NewsRegulatory News

    CHMP recommends 12 new medicines, including first RSV treatment for infants

    The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to prevent respiratory syncytial virus (RSV) in newborns, driving the total number of endorsed treatments to 70 since the beginning of the year. Five of the 12 approval recommendations are for orphan drugs.   The new RSV treatment, Beyfortus (nirsevimab) developed by AstraZeneca and Sanofi, was s...
  • Feature ArticlesFeature Articles

    ARTICLE OF THE YEAR: The linguistic review process in the centralized procedure in the EU

    In the EU and European Economic Area (EEA), certain products receive marketing authorization through the centralized procedure (CP). Following this, a number of documents, such as the product information (PI), require translation into all 24 EU and EEA official languages. The translations provided by the marketing authorisation holder (MAH) are approved by the corresponding EU member states. This review and approval process of the 24 languages is known as the linguistic re...
  • RF Quarterly

    China’s NMPA: The evolution of medical device regulation

    This article describes the main changes of China's drug and device regulatory system in the past 70 years, with the focus on medical devices rather than drugs. The article highlights the latest changes in the regulation of medical devices and examines international cooperation in the field of medica devices and the regulatory framework for the medical device product life-cycle in China. It also includes the latest updates for medical device regulation in 2022 and beyond. ...
  • Regulatory NewsRegulatory News

    FDA explains when it will rescind breakthrough designations

    The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its evaluation of a drug.   While FDA has long asserted its authority to rescind or withdraw BTDs, the new guidance will add clarity for sponsors as to when the agency might revoke the designation. Since designation was created under the Food and Drug Administration Safety and Innovation Act in 2012,...
  • Regulatory NewsRegulatory News

    First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing

    The US Food and Drug Administration (FDA) has authorized the first in vitro diagnostic to help diagnose early Alzheimer’s disease. The agency said the test minimizes radiation risks to patients who otherwise would need to be tested with positron emission tomography (PET) scans.   On 4 May, FDA announced it has given the green light to Fujirebio Diagnostics’ de novo application for its Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is intended for patients ages...
  • Regulatory NewsRegulatory News

    Industry guidance aims to help manufacturers adhere to bar coding requirements

    The Healthcare Distribution Alliance (HDA) on Monday issued a guide to help the pharmaceutical industry in formatting and placing bar code labels on their products to comply with Drug Supply Chain Security Act (DSCSA) requirements for tracking products through the supply chain.   DSCSA was signed into law in November 2013 and outlines the necessary steps necessary to build and electronic, interoperable system to identify and trace prescription drugs distributed in ...
  • Regulatory NewsRegulatory News

    EU adopts common standard for electronic product information

    European regulators on Tuesday announced the adoption of a common electronic product information (ePI) standard for human medicines that can be accessed by users and healthcare providers alike.   ePI is beneficial because it can be updated and disseminated to stakeholders immediately, without having to wait for new information to be formatted and printed, European Medicines Agency officials said in a statement . EMA released the standard along with the European Commis...
  • Regulatory NewsRegulatory NewsRAPSRAPS' Latest

    Orphan drug experts discuss new book on developing rare disease treatments

    Developing therapies for rare diseases involves complex incentives, unique requirements, and often extensive patient engagement. The authors of RAPS’ Orphan Drug Development for Rare Diseases , Sundar Ramanan, PhD, MBA, and Sunny Kamlesh Dave, MPharm, recently took time to discuss with RAPS Senior Editor Gloria Hall the importance of orphan drugs, the peculiarities and challenges of obtaining an orphan drug designation (ODD), and what is covered in the book. During a “m...
  • Feature ArticlesFeature Articles

    Regulatory advertising & promotion: Bringing value beyond the day-to-day

    While the primary goal of the clinical development team is to obtain product approval, companies must have a broader vision that supports the complete product lifecycle. Experts in regulatory advertising and promotion (A&P) have a detailed knowledge of the US Food and Drug Administration (FDA) requirements for product promotion. Beyond supporting the promotional review process, the unique skill set of regulatory A&P should be applied to other critical activities, including...
  • Feature ArticlesFeature Articles

    EU regulation of herbal products, Part 2: Quality, safety and efficacy, and postmarket surveillance

    The article compares and contrasts the regulatory requirements for herbal medicinal products (HMPs), herbal-based medical devices and botanical food supplements in the EU. It is part 2 of a two-part article – Part 1 presented the definitions, main regulations, and documentation requirements for placing the products on the market; Part 2 will address quality, the strength of evidence supporting the safety and efficacy, and postmarket surveillance (PMS) requirements across...
  • Feature ArticlesFeature Articles

    The RACE is on: Opportunities in pediatric oncology product development

    Pediatric oncology patients continue to have significant unmet medical need. Although the Pediatric Research Equity Act (PREA) mandated evaluation of new drugs for pediatric patients, the rarity and uniquity of pediatric cancers allowed for waivers or exemptions from PREA requirements. The passing of FDA Reauthorization Act amendments in 2017 included the Research Acceleration for Cure and Equity Act, which expands the scope of oncology products subject to PREA. Sponsors d...