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    Medical device software under the EU MDR

    The EU Medical Device Regulation (MDR) has been published with new medical device software (MDSW) requirements. Qualification guidance to determine if software is MDSW was combined with guidance for MDSW classification. However, the EU Medical Device Directive (MDD) guidance for clinical evaluation, which should have been replaced, is still in use. The change to the MDR has introduced new problems for clinical evaluation, so guidance has been introduced for equivalence, le...
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    Impact of the COVID-19 pandemic on aspects of regulatory advertising and promotion

    This article discusses the impact of the COVID-19 pandemic on aspects of regulatory advertising and promotion. The author discusses how the shift from print to digital promotional strategies has affected certain elements of the regulatory review process and highlights considerations for carrying these learnings forward after the pandemic.   Introduction Almost a year out from the onset of the pandemic, COVID-19 continues to present challenges for regulatory adverti...
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    December's Regulatory Focus: APL and the role of social media

    December 2020. It’s been just one year since we finished the last Regulatory Focus issue on advertising and labeling, yet it feels like a lifetime. In March, as the true impact of COVID-19 kicked in and we retreated from the office space to our home offices, it was hard to envision how we would prevail, both personally and professionally. But our industry, and particularly regulatory advertising and labeling, did not skip a beat and instead, stayed the course and perseve...
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    10 lessons learned during my first year in ad promo

    After completing my industry rotation as a 4th year pharmacy student, I knew I wanted to pursue a career in regulatory affairs (RA) advertising and promotion. I had the opportunity to attend a meeting for a branded promotional piece with medical, regulatory, legal, and marketing representatives and instantly I was drawn to the conversation and the overall collaborative process. I remember being so engaged in the discussion that I even made a proposal that was accepted by t...
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    Preparing for advertising and promotion eCTD submissions in the US

    This article provides the sponsor’s perspective and best practices on facilitating electronic common technical document (eCTD) submissions for promotional materials as a shared learning for other companies.   Introduction The long-awaited June 2019 guidance 1 on regulatory submissions in electronic and nonelectronic format marked the beginning of a two-year countdown for sponsors to submit promotional materials in eCTD format to the Office of Prescription Drug Pro...
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    Building bridges through communication: Lessons learned in 2020

    The global pandemic has created many challenges this year for regulatory professionals, especially in the way it has transformed workplace interaction and communication. This article provides some helpful tips on video conferencing, phone calls, active listening, and trending business applications as a way of sharpening communication skills and improving business and regulatory interactions.   Introduction Regulatory affairs (RA) can be structured differently across ...
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    Optimizing metadata fields for promotional material review in the US

    Metadata fields are extremely useful tools for classifying and managing the promotional materials used in the commercialization and marketing strategy of pharmaceutical companies and their drugs. Optimizing such fields by implementing various levels of customization and configuration can help individualize the review systems used for promotional material review in the US. These potential changes can strengthen processes to conduct cross-functional, risk-based decision maki...
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    Leveraging digital/social media platforms to meet business goals: A US case study

    This article discusses considerations for compliantly leveraging digital and social media platforms to meet pharmaceutical business objectives in the US. The authors outline the approach of Otsuka America Pharmaceutical Inc in developing processes, reviewing and approving digital/social media content, and electronic Form FDA 2253 submissions of related promotional materials.   Introduction Since the onset of social media in the early 2000s, pharmaceutical manufacture...
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    A deep dive into OPDP’s position on public health emergencies in the US

    This article explores the Office of Prescription Drug Promotion’s (OPDP’s) views on public health emergencies, including COVID-19, and how this affects drug promotion. The author reviews trends in past enforcement letters and concludes that promotional materials relating to current public health emergencies are heavily scrutinized by OPDP, which regulatory advertising and promotion reviewers should bear in mind.   Introduction The COVID-19 pandemic has caused innumer...
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    Q4 Regulatory Focus Article Series: Regulatory Intelligence

    Q4 Regulatory Focus Article Series: Regulatory Intelligence   RAPS is pleased to bring you another edition of its Regulatory Focus Article Series, comprised of timely and relevant technical articles, case studies, interviews, and research reports. These topic-focused collections are intended to benefit RAPS members responsible for healthcare-related products. Articles are developed by global subject-matter experts representing a range of regulatory responsibiliti...
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    OPDP compliance and promotional considerations for podcasts and audio-streaming

    This article discusses the increasing interest and trend in using podcasts and audio-streaming platforms for promotional and nonpromotional activities, and how that relates to the pharmaceutical industry. The author provides a rudimentary overview of current landscape, as well as promotional considerations from a regulatory perspective to maintain compliance with the Office of Prescription Drug Promotion (OPDP) of the US Food and Drug Administration (FDA). Communication an...
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    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...