• 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 Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the nonclinical studies drugmakers should conduct when developing products to treat severely debilitating or life-threatening hematologic disorders (SDLTHDs).   FDA classifies SDLTHDs as hematologic conditions that cause shorter life expectancy or greatly diminished quality of life even with available treatments.   FDA notes that the guidance does not apply to hematologic cancers and covers...
  • Regulatory NewsRegulatory News

    FDA Warns Jubilant, Pfizer Subsidiary in India

    The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...
  • Regulatory NewsRegulatory News

    CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway

    Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office." The so-called "Total Product Life Cycle 'Super' Office" will integrate premarket, postmarket surveillance and quality-compliance functions, Shuren said, noting it will be "a big deal." The o...
  • Regulatory NewsRegulatory News

    NICE Halts Plans to Charge for Appraisals

    The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy. The controversial plan to charge for appraisals, first unveiled in October , would see companies pay fees of up to £282,000 for each cost-effectiveness assessment. NICE’s chief executive, Sir Andrew Dillon, said...
  • Regulatory NewsRegulatory News

    Ethical Guidelines for Human Research Revised

    The Council for International Organizations of Medical Sciences (CIOMS) last week finalized the latest revision to its ethical guidelines for health research involving human participants. According to CIOMS, the revision aims to address challenges and shortcomings with the previous revision from 2002, especially related to value and fairness of research involving human subjects. In 1982, CIOMS released its first set of guidelines aimed at creating a set of international...
  • Regulatory NewsRegulatory News

    Brexit Rejig: UK Taps Three Leaders to Helm Office for Life Sciences

    The UK’s Office for Life Sciences, which will continue to be a joint unit across the Department of Health (DH) and the newly formed Department for Business, Energy, and Industrial Strategy (BEIS), on Thursday selected three new ministers to lead. In the DH, two ministers will be jointly responsible for life sciences, including: Lord Prior of Brampton, Parliamentary Under Secretary of State for Health and former adviser to the health authority of Abu Dhabi, who will lea...
  • Regulatory NewsRegulatory News

    Researchers Question Consistency of FDA’s Use of Surrogate Endpoints for Drug Approvals

    The US Food and Drug Administration (FDA) is not consistent with its use of surrogate endpoints in assessing the risks and benefits of treatments for some diseases, making it difficult to assess the treatments' actual clinical effects on outcomes important to patients, according to researchers from Johns Hopkins. The researchers came to this conclusion after evaluating 58 FDA drugs approved between 2003 and 2012 for chronic obstructive pulmonary disease (COPD), Type 1 an...
  • Feature ArticlesFeature Articles

    FDA’s Expedited Programs for Serious Conditions: An Overview

    For some serious or life-threatening diseases, few therapeutic options exist. Once a promising therapy is discovered, establishing its clinical benefit and safety profile is necessary but can be time consuming. Standard drug development programs involve formulating and manufacturing the drug product, characterizing the new drug, gathering adequate evidence on its performance, evaluating the safety risks and confirming the effects observed in the early clinical trial...
  • Regulatory NewsRegulatory News

    Singapore Regulator Alleges Fake Lab Report Used on Facebook Page

    Singapore’s healthcare product regulator, the Health Sciences Authority (HSA), is alleging that a Malaysian dietary supplement company used falsified lab reports when promoting one of its products on its Facebook page and blog. A Warning on Facebook The company, Champion Club International Sdn Bhd, was warned about the Facebook post by HSA in a 23 December 2014 update on the regulator's website . The update clarifies that the product in question, known as "E250," is ...
  • Regulatory NewsRegulatory News

    Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

    Finding information about the latest regulatory news can be profoundly difficult. Even with thousands of websites, hundreds of newsletters and dozens of subscription services, information that could affect you and your company can still slip through the cracks. Luckily, there's help, and lots of it—but only if you know where to look. Regulatory Intelligence on … Twitter? One of the most under-utilized sources of regulatory information is Twitter , a social media platf...
  • Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

    The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority but critics have derided as the regulation of the practice of medicine. A 24 September warning letter to Texas-based CellTex Therapeutics Corporation references the firm's use of adipose tissue (lipoaspirate) recovered from donors, which is then isolated and cultured into adi...