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  • 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...
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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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    New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety

    A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms. The study, conducted by researchers at Harvard Medical School, Northeastern University, Boston Children's Hospital and The Ohio State University, and funded by FDA's Center for Drug Evaluation and Research, looks specifica...
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    FDA Enforcement Trends for Broadcast Advertisements

    This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information. Introduction From January 2016 through Augus...
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    Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Prepares Changes to Advertising Complaints Process The Therapeutic Goods Administration (TGA) of Australia is seeking industry feedback on the reform of the advertising complaints management process. TGA is considering either setting up a centralized process for handling complaints or outsourcing some or all of the work to an independent authority and wants to get...
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    European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System A senior politician overseeing the United Kingdom’s exit from the European Union has dismissed the need to retain certain aspects of the country’s current regulatory model post-Brexit. Asked in the House of Commons whether he agreed with industry leaders on the need for the UK to be part of a Europe-...
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    Drug Marketing on Twitter: FDA to Study Space-Limited Communications

    The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited. "The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about the drug are made within character-space-limited communicati...
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    The Importance of Internal Systems to Support Social Media Campaigns

    This article discusses the importance of internal systems to ensure social media and marketing campaigns are in compliance with FDA requirements. Increasingly and on a daily basis, people are using social media to market drugs, medical devices and other medical products. When we think of social media, we typically think of Facebook and Twitter. However, social media may be considered anything in the public domain, including on a website, TV or radio program where a com...
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    Using Social Media to Promote FDA-Regulated Products - A Balanced Approach is Best

    This article shares some of the current thinking on best practice uses of social media in promoting FDA-regulated products. In today's world, the use of social media in pre- and post-marketing activities for FDA-regulated products must be considered and utilized carefully. Appropriate social media use will help to ensure patient safety by disseminating accurate and complete information about a product and/or health condition, and in doing so, it will meet the requireme...
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    Pharmaceutical Marketing via Social Media

    This article discusses the ongoing effort by the pharmaceutical industry to use social media as a marketing tool. It presents benefits and limitations of using this form of media and describes recent progress in public communication. Pharmaceutical marketing is the practice of promoting and selling medicines to patients through different media. The broad scope of this definition encompasses all means for the purpose of marketing and sales adopted by a company. A drug c...
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    FDA to its Scientists: Feel Free to Engage on Social Media

    The US Food and Drug Administration (FDA) is now encouraging its employees to use social media in a personal capacity, particularly for sharing information that may benefit public health, as long as employees make clear that their opinions aren’t the views of the agency. The new policy, released last week, clarifies that employees do not need to obtain permission or approval from FDA supervisors or agency management to use social media in a personal capacity, although “e...
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    Walking the Digital Tight-Rope

    On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media. Most likely, you are currently reading this on your iPad, smart phone or computer screen as are the majority of people seeking information in this digital-age. To align with current user-practices, Regulatory Focus magazine moved to a completely digital format in 2012. Along the same vein,...