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  • 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 ...
  • Regulatory NewsRegulatory News

    The Top 15 Biologics Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of biologics manufacturing facilities, indicating the most common issues faced by biologics companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 146 Form 483s—forms indicating areas of noncompliance at a facility—to biologics companies in fiscal year 2014. T...
  • Regulatory NewsRegulatory News

    FDA Targets Companies for Facebook 'Likes.' Is Twitter Next?

    Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might so...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Warns Company for 'Liking' Status on Facebook

    The US Food and Drug Administration (FDA) has issued a rare Warning Letter chiding a company for, among other reasons, improperly "liking" certain unapproved claims about its product on Facebook. The letter, sent to Utah-based dietary supplement manufacturer Zarbee's, is primarily focused on the company's marketing claims, which FDA says cause the company's products to be drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under federal law, dietary supple...
  • Regulatory NewsRegulatory News

    FDA Guidance: How Can Pharma and Device Companies Use Twitter? Not Easily.

    The US Food and Drug Administration (FDA) today released two guidance documents focused on the use of social media by members of regulated industry, including one on how companies can use the social media platform Twitter and other space-limited platforms. Background The issuance of guidance on social media was required by the  Food and Drug Administration Safety and Innovation Act ( FDASIA ) , Section 1121 of which calls for FDA to, by August 2014, "issue gui...
  • Industry Sees Much not to ‘Like’ in FDA's First Social Media Guidance Document

    In January 2014, the US Food and Drug Administration (FDA) released the first of what it said would be many guidance documents intended to clarify the use of social media by life sciences companies. Now the life science industry is weighing in on that draft guidance, calling for changes and clarifications. Background: Social Media and FDA The pharmaceutical industry's advertising and promotional materials are tightly regulated by FDA and the Federal Trade Commission (FT...
  • FDA Using Twitter, Telenovelas and Translations to Reach Non-English Speakers

    If you're reading this article, chances are good you take something for granted every day: your ability to read. But even beyond that, the fact that you're reading Regulatory Focus means you're probably fluent in English and well-versed in medical terminology. Many Americans, though, can't read, can't read or speak English, or can't read or speak English well enough to understand the medical terminology that is necessary to interpret the labels on medical products like...
  • Regulatory Reconnaissance (2 August 2013)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking every Friday off in August for vacation, but is making sure to keep you up-to-date with Regulatory Reconnaissance. In Focus: "Would Have Written About These" Highlights BIO Whitepaper Calls for 12 Years of Biologics Exclusivity in Trade Deal ( BIO ) ( BIO ) BIO, PhRMA, AdvaMed, GPhA, MITA Join Together to Support Senate Bill to Exempt FDA User Fees from Se...
  • Could FTC's New Social Media Guidance be Similar to one Pending at FDA?

    If pharmaceutical and medical device companies are eagerly awaiting the US Food and Drug Administration's (FDA) social media guidance for promoting their products using social networks like Twitter and Facebook, a new guidance released by the US Federal Trade Commission (FTC) may provide some insight into how the agency will treat mobile and social advertising. Background: Authority FTC and FDA operate under a slightly unusual agreement in which FTC voluntarily cedes so...
  • In Midst of Crackdown, New Batch of FDA, FTC Warning Letters Target Unapproved Flu Products

    The US Food and Drug Administration (FDA) has released a bevy of new warning letters all aimed at "unapproved flu products," part of a recent crackdown by the agency on products it deems to be either ineffective or potentially dangerous. Background The 2012/2013 flu season has been a particularly strong one in the US, and high public demand for flu vaccinations has put FDA on edge, and for good reason: The combination of drug shortages and public concern is a potent rec...
  • The 25 Regulatory Twitter Accounts You Need to be Following

    Here at Regulatory Focus , we love Twitter. The micro-blogging website, occasionally more noted for its celebrity handles, parody accounts, over-shared information and boring observations is also something most people don't realize: an excellent tool for gathering regulatory intelligence. Call it social media regulatory intelligence, if you will. Between the editors and other staff here at Focus , we follow over a thousand people on Twitter, ranging from reporters to ...