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  • Regulatory NewsRegulatory News

    FDA Warns Imprimis for False and Misleading Website and Twitter Promotions

    The US Food and Drug Administration (FDA) late last month sent a warning letter to San Diego-based Imprimis Pharmaceuticals for false and misleading claims made on the company’s website and Twitter account, among other violations. FDA said that for two products – "Simple Drops" and "Klarity C-Drops" – the company claims they are made with FDA approved components or are FDA-approved, "when that is not the case."  In addition, FDA said Imprimis' website makes false...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    PhRMA, Lilly and AbbVie Weigh FDA Plan to Study Twitter Drug Ads

    When the space of characters is limited, can a link to risk information be enough for drugmakers advertising their products on social media like Twitter? That’s the question the US Food and Drug Administration (FDA) asked last November and now industry is offering their opinions on the planned studies. As part of its planned study, FDA said on 7 November that it plans to conduct four studies, two involving Twitter and two using Google sponsored links, to determine how ...
  • Regulatory NewsRegulatory News

    Top Ten Stories From 2016 by Traffic

    Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading! Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers : A perennial favorite, this explainer breaks down the latest in the lucrative world of PRVs. Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017 :...
  • Regulatory NewsRegulatory News

    Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

    With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical device spaces, for investors, and even for the regulators themselves, Twitter is a great place to catch the day’s breaking news before the headlines are written. (Editor’s Note: This is by no means a complete list and if you’re looking for more than 85 accounts, you’re in...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    What Is 'Regulatory Intelligence?'

    This article provides an overview of regulatory intelligence, including identifying sources, using tools for gathering information, and the importance of recognizing copyright restrictions . Regulatory intelligence is the regulatory information you have been asked to gather and provide regarding topics of importance to your audience. For example, you may be asked to inform your company of any medical device-related items in the Federal Register or of FDA warning or un...
  • Regulatory NewsRegulatory News

    In Focus: The Top News Stories from 2015

    For RAPS’ Regulatory Focus , 2015 might simply be called: The Year of the Explainer. With major legislation altering the inner workings of the US Food and Drug Administration (FDA), as well as new priority review voucher programs coming to fruition, RAPS’ reader interest has been spiking for longer, more in-depth articles. Without further ado, here are the top most-read articles in 2015 based on traffic statistics: 9. After Three-Year Delay, FDA Finalizes Guidance Do...
  • Regulatory NewsRegulatory News

    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...
  • 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...
  • Regulatory NewsRegulatory News

    The First Quarter in Focus: Our Top 10 Stories of 2015 (So Far)

    It's already been a busy, busy year here at Regulatory Focus. During the first quarter alone, more than a quarter million of you have read more than half a million of our articles—a new record for Focus , and hopefully a testament to the value of the content we're producing on a daily basis. But which articles have attracted your collective attention the most? Read on to discover the top 10 articles in Focus so far this year. The Top 10 10.) FDA Launches New Drug ...