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  • Feature ArticlesFeature Articles

    December’s Regulatory Focus: Advertising, promotion, and labeling

    Feature articles during December focused on advertising, promotion, and labeling (APL), examining regulatory review of advertising on streaming media, the role of the regulatory A&P professional, the importance of metrics in APL, and the regulatory outlook for telehealth A&P. Also included is the second part of a two-part series on EU regulation of herbal products, examining quality, safety and efficacy, and postmarket surveillance.   Last year this time, the issue co-...
  • Feature ArticlesFeature Articles

    The regulatory outlook for telehealth advertising and promotion

    The global pandemic has increased the use of telehealth and accelerated its acceptance into mainstream healthcare. However, the regulatory landscape has yet to fully catch up with this expansion of telehealth. This article discusses some of the potential advertising and promotional regulatory implications as telehealth becomes a mainstay in the ever-evolving healthcare sector. The article explores the advertising and promotion of off-label drug prescriptions by telehealth ...
  • 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

    Regulatory review of advertising on streaming media

    This article discusses advertising on streaming media and what regulatory reviewers need to take into consideration when reviewing online videos.   Introduction Television. One word, many meanings – it could be the wide-screen home TV, the latest Hulu-exclusive series we binge-watch on an iPad, or the 5-minute Snapchat original series that releases a new episode every week. There is no shortage of places for consumers to view video content outside of a traditional ...
  • Regulatory NewsRegulatory News

    FDA studies consumer perception of DTC drug ads, willingness to report false claims

    The US Food and Drug Administration (FDA) is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on how to measure consumer perceptions of the information presented in ads.   In a recent Regulatory Science in Action article , the agency outlined findings from three studies looking at the role of images in advertising, the development of valid measures to assess perception of ads, and the likelihood that physicians and consume...
  • Regulatory NewsRegulatory News

    OPDP warns AcelRx over Dsuvia promotional materials

    In its first warning letter of the year, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week cited AcelRx Pharmaceuticals over promotional materials for its opioid analgesic Dsuvia (sufentanil sublingual tablet).   Specifically, the warning letter cites the company for false and misleading claims made in banner ads and a tabletop display that feature a tagline promoting the ease of administration of Dsuvia as “Tongue a...
  • Feature ArticlesFeature Articles

    January’s Regulatory Focus: The impact of disruption on the global regulatory community

    Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways for test kits in southeast Asian countries; the role of digital promotional strategies in minimizing the impact of the pandemic on advertising, promotion, and labeling; and the importance of continuing soft-skills training during remote working. Under the broader framework of disruption, a group o...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    FDA to Survey Healthcare Professionals on Prescription Drug Marketing

    The US Food and Drug Administration (FDA) on Friday announced it will go ahead with a survey of healthcare professionals (HCPs) on how they are impacted by prescription drug promotion aimed at a professional audience.   The announcement comes after the agency consulted on its plans for  the survey in March 2018 and follows two earlier surveys that looked at HCPs’ attitudes toward direct-to-consumer (DTC) advertising. The survey will also include questions about HCPs’...
  • Regulatory NewsRegulatory News

    OPDP Letters: FDA Closes Out 2017 With Record Low

    In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP). The warning letter brings the total number of enforcement letters issued by OPDP in 2017 to four (three warning letters and one untitled letter), a record low for the agency. Whi...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Promotional Drug Labeling and Ads

    The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs. FDA said it received one comment on the revised draft guidance, and in addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised dr...