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-leads, Moulakshi Roychowdhury and Linda Pollitz, highlighted how COVID-19‒related restrictions on in-person promotional activities pushed regulatory AP professionals to be more agile and flexible in rethinking their approaches to their work to ensure continued delivery of quality information to patients and healthcare providers. Those efforts carried through to 2021, with APL professionals consolidating their collective lessons learned and further honing their skills to meet their goals. This collection of articles encapsulates their successes and new insights and offers useful, tried-and-tested guidance for APL professionals.
 

Appreciation and acknowledgments

RAPS thanks the Editorial Advisory Committee for its generosity in providing invaluable insights and expert guidance during 2021. The peer-review process is integral to ensuring the quality and relevance of our content and its contribution to existing regulatory literature. To that point, we extend our gratitude to the RAPS technical reviewers and, once again, the EAC for their thoughtful and constructive feedback on submitted articles.    
 
We also thank the 2021 authors for sharing their expertise and knowledge with their regulatory colleagues and hope many others will consider contributing articles during 2022 (see Guidelines for Authors and the 2022 Editorial Calendar).
 
We wish the Regulatory Focus community a happy, healthy, and successful 2022. We value your interest in the publication and look forward to continuing to provide you with timely, quality content you can use as a resource in your work.
 

December issue Table of Contents 

Regulatory review of advertising on streaming media  
          Olivia Walker and Shruti Gadhia 
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Regulatory advertising & promotion: Bringing value beyond the day-to-day
          Kristen Heinlein
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The role of metrics in regulatory advertising and promotion
          Malyha Mannan
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The regulatory outlook for telehealth advertising and promotion
          Carly Small, Anthony Haddad, and Vilson Gashi
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EU regulation of herbal products, Part 2: Quality, safety and efficacy, and postmarket surveillance
          Andrada Armasu
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Upcoming in Regulatory Focus
What’s coming in January?
Articles during January will examine Leadership in regulatory affairs. Look for this topic and more throughout January at Regulatory Focus. The submission due date for articles has been extended to 21 January 2022. To contribute, email rmatthews@raps.org.
 
And February?
For the February issue, the topic will be Impact of noncompliance. The submission due date for articles has been extended to 7 February 2022. To contribute, email rmatthews@raps.org.
 
Call for articles
March 2022 issue
In March 2022, Regulatory Focus will cover Regulatory Intelligence. The submission due date for articles is 1 February 2021. To contribute, email rmatthews@raps.org.
 
Also see 2022 Editorial Calendar.
 
Upcoming in RF Quarterly
Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit. The most recent issue, focusing on quality and compliance, is available.
 
Topics through 2022 will be:

• Software as a medical device (March 2022)
• Regulatory history (June 2022)
• Strategy in regulatory affairs (September 2022)
• Artificial Intelligence (December 2022)

To contribute to the upcoming issues, email rmatthews@raps.org.

Previous issues of RF Quarterly

• Global clinical trials
• Artificial intelligence in regulatory affairs
• Quality and compliance

 
For more information about monthly articles and RF Quarterly, see Guidelines for Authors and the 2022 Editorial Calendar.