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  • RAPS' LatestRAPS' Latest

    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,...
  • Feature ArticlesFeature Articles

    FDA Social Media Guidance–Lessons Learned from the Comment Period

    This article reviews and summarizes public comments on FDA's two draft social media guidance documents. In the past, traditional drug and device promotion came in the form of paper collaterals–sales aids, booth panels, slim jims* and the like. As we entered the internet age, companies found new avenues to get their product promotional messages out. Broadly defined as "social media," new forms of product communication now include interactive websites with sharing capabi...
  • Feature ArticlesFeature Articles

    Social Media: Changing the Rules for Regulatory Professionals

    This article discusses social media's role in the changing regulatory landscape and how regulatory professionals must evolve to ensure compliance with FDA requirements specific to the medical device field. As social media rapidly evolves via the internet, digital media platforms, new technologies and mobile applications enhancing the marketers' ability to create and deliver more personalized, segmented solutions to medical device users, regulatory professionals also ne...
  • Feature ArticlesFeature Articles

    The Evolving Approach of Presenting Risk Information to Consumers

    This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency. In recent years, there has been an increased focus from the US Food and Drug Administration (FDA) on consumer directed promotional materials. Nearly all of the active research projects at the Office of Prescription Drug Promotion (OPDP) are focused on how consumers respond to the type or presentation of risk inf...
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    Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event

    Advertising and promotion of healthcare products in the US are strictly regulated by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. On Wednesday, 3 June, RAPS...
  • Regulatory NewsRegulatory News

    Free the Tweets: Group Asks FDA to Allow its Scientists to Use Social Media

    The US Food and Drug Administration currently lacks any policy permitting its employees to discuss scientific issues on social media channels like Twitter and Facebook, a new report by the scientific advocacy group Union of Concerned Scientists (UCS) has found. The findings, outlined in the report " Grading Government Transparency: Scientists' Freedom to Speak (and Tweet) at Federal Agencies ," are meant to spur discussion about whether FDA's employees are free to speak ...
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    FDA Cracks Down on Facebook Marketing With Four New Letters to Companies

    The US Food and Drug Administration (FDA) is increasingly paying attention to social media, and in particular Facebook, as companies use the social networking platform to market their products. Six Warning Letters in Six Months In at least six Warning Letters issued since October 2014, FDA has referenced promotional claims used to market products on Facebook. Warning Letter Issued to: Reason for Letter Date Issued Vitalab Co., Inc. Unapproved Claims 16 Octo...
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    FDA Seeks New Top Press Official for its Office of Media Affairs

    The US Food and Drug Administration (FDA) has started its search for a new leader for its Office of Media Affairs , better known simply as FDA's Press Office. In a job notice posted on 2 March 2015, the agency said it's looking for a new assistant commissioner for media affairs—a position which has long been in a state of flux. The office is currently overseen by Acting Assistant Commissioner Heidi Rebello, who took over from former Acting Assistant Commissioner Eric...
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    UK Regulator Releases Advertising Report, Complaints Down 32% from 2013

    The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its annual report on drug advertising. The agency says complaints are down versus previous years, but notes it received more complaints about advertisements made on websites and social media. Background In addition to adhering to the general advertising rules in the UK, companies are expected to voluntarily comply with the standards for drug advertising and promotio...
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    Singapore Regulator Alleges Fake Lab Report Used on Facebook Page

    Singapore’s healthcare product regulator, the Health Sciences Authority (HSA), is alleging that a Malaysian dietary supplement company used falsified lab reports when promoting one of its products on its Facebook page and blog. A Warning on Facebook The company, Champion Club International Sdn Bhd, was warned about the Facebook post by HSA in a 23 December 2014 update on the regulator's website . The update clarifies that the product in question, known as "E250," is ...
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    FDA to Spend $16M to Track National Prescribing Trends

    The US Food and Drug Administration (FDA) is preparing to put more than $16 million into a multi-year program intended to provide regulators with data on how US patients are prescribed drug products. The data, including medical claims data, is meant to provide regulators with the ability to see which drugs are being used by patients, for how long and with what other drugs. Regulators are also looking to pair that data up with basic demographic data on patients, such as a...
  • Regulatory NewsRegulatory News

    Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

    Finding information about the latest regulatory news can be profoundly difficult. Even with thousands of websites, hundreds of newsletters and dozens of subscription services, information that could affect you and your company can still slip through the cracks. Luckily, there's help, and lots of it—but only if you know where to look. Regulatory Intelligence on … Twitter? One of the most under-utilized sources of regulatory information is Twitter , a social media platf...