• Feature ArticlesFeature Articles

    The mentor-mentee relationship: Surviving remote work

    Mentorship is an important aspect of professional growth. The COVID-19 pandemic disrupted how regulatory professionals interact with colleagues. This article discusses the benefits mentees and mentors gain from mentorship relationships and steps to consider when trying to build a mentor-mentee relationship – in-person or remote. It explores the dynamics of mentorship and its value for advancing a regulatory professional’s career.   Keywords – mentorship, networking,...
  • Regulatory NewsRegulatory News

    FDA describes plans to expand remote regulatory assessments

    The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.   These tools are not intended to replace onsite inspections but inste...
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    Remote interactive evaluations: FDA official discusses lessons learned

    To ensure the success of remote interactive evaluations (RIEs), the pharmaceutical industry should treat these evaluations with the same level of attention to detail as onsite inspections,  said Alexander Gontcharov, a staff fellow with the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) during the second day of FDA’s Generic Drug Forum on 27 April.   At the meeting, Gontcharov shared some of the lessons learned from the agency’s intera...
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    Stakeholders want more clarity about devices used for remote clinical studies

    A number of stakeholders have written to the US Food and Drug Administration about the agency’s recent draft guidance on how digital health technologies (DHT) could be used to conduct clinical trials remotely. Some have concerns about the agency too narrowly defining what products can be used for remote monitoring, while others argue it’s not broad enough. Some are also asking the agency to include smart packaging in the guidance.   In December, the agency published i...
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    Kaleido warned; FDA not persuaded by 'medical food' claim

    The US Food and Drug Administration (FDA) recently issued a warning letter to Kaleido Biosciences for administering an investigational new COVID-19 treatment to patients without obtaining an investigational new drug (IND) application.   The company argued that the product under investigation was a food and not a drug, and therefore not subject to IND filing requirements. Yet the agency disagreed, saying that the endpoints used in the clinical trials went beyond ‘diet...
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    EMA offers new Q&A on data monitoring committees

    The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and management of clinical trials.   EMA explains that the recommendations of DMCs are not binding for trial sponsors, but that sponsors should justify and document and instances where such recommendations are not followed.   “The ultimate responsibility for a clinical trial re...
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    Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance

    Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring (RBM) of clinical trials. The eight-page RBM draft guidance , released in March, comes in the form of eight questions and answers. It expands on guidance from August 2013, known as “ Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring ,” by providing...
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    Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia . CFDA Posts Draft Medical Device Adverse Event Monitoring Guidance China’s Food and Drug Administration (CFDA) has posted draft guidance on post-marketing supervision of medical devices. The guidance sets out the role regional and national regulators, medical device manufacturers and adverse event monitoring technology institutions will play in tracking the safety of...
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    FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems

    • 07 October 2016
    The Food and Drug Administration (FDA) on Friday finalized two guidance documents related to blood glucose monitoring systems (BGMSs), offering new recommendations on the different types of information in 510(k)s for BGMSs used by health professionals versus SMBGs intended for home use by lay users. FDA says the guidance was necessary as it has become increasingly clear that these different use settings have distinct intended use populations with unique characteristics...
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    The New KYSS Principle: Know Your Supplier's Supplier

    • 27 May 2016
    This article introduces the KYSS principle to align a robust supplier management program with regulatory requirements and includes initial identification and qualification of suppliers, supplier quality agreements and both initial and ongoing supplier monitoring. Introduction Deaths, illnesses, injuries and many recalls have been attributed to fraudulent, counterfeit or adulterated components of finished pharmaceuticals and medical devices. 1 These tragic consequence...
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    Health Canada Finalizes IVD Labeling Guidance After 18 Years

    The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998. The final guidance includes new considerations for electronic labeling, IVDs with small containers, blood glucose monitors and information on complying with Canada's Official Languages Act , which requires product labels to be written in both French and English. Additionally, the guidance...
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    Asia Regulatory Roundup: CFDA Consults on Good Supply Practices, Traceability (23 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Reviews Good Supply Practices After Suspending Ali Health-run Platform The China Food and Drug Administration (CFDA) has begun a consultation on good supply practices and traceability after suspending the use of a drug monitoring system run by Alibaba-subsidiary Ali Health. In revising its traceability document, CFDA has removed references specific to the electro...