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  • FDA Says Many Social Media Guidances on the Way, but Claims FDASIA Deadline has Already Been Met

    For years, members of the pharmaceutical industry have awaited the release of what has been dubbed by many as "The Social Media Guidance," a document intended to explain in full detail how companies could use social media platforms to advertise and promote their products while meeting the US Food and Drug Administration's (FDA) strict regulatory requirements. There's just one problem, according to FDA officials: There is no single social media guidance in development. ...
  • FDA Releases (its Other) Social Media Guidance

    It may not be the social media guidance members of the pharmaceutical industry have be clamoring for, but the US Food and Drug Administration (FDA) today released a draft guidance document that offers some insight into how the agency thinks companies should use-and not use-social media channels. Background The pharmaceutical industry's advertising and promotional materials are tightly regulated by FDA and the Federal Trade Commission (FTC), the latter of which has veste...
  • Shaking Off Prior Criticism, FDA Forges Ahead with Additional Social Media Monitoring Plans

    The US Food and Drug Administration (FDA) recently issued a notice indicating that it is seeking the services of a company to help it monitor online sentiment, keep abreast of social media conversations and even determine "influencers" to better target its outreach. The FDA " Sources Sought " notice was posted on 23 December 2013 to the government's Federal Business Opportunities (FBO) website. Existing Plans It is similar in many respects to an earlier contract a...
  • How Can Reddit be Used as a Regulatory Intelligence Tool?

    The sheer volume of news and information sources regulatory professionals need to stay abreast of can be daunting at best. Here at Focus , we track thousands of websites and social media accounts to bring you daily snapshots of the news that matters most to regulatory professionals. But there's another source of information out there that can prove valuable in its own way, one widely neglected by the life science and regulatory communities. Over the last few years,...
  • FDA to Spend up to $182,000 on Social Media Tool to Shape, Monitor Communications

    In July 2013, the US Food and Drug Administration (FDA) quietly announced through its Federal Business Opportunities (FBO) page that it was seeking a partner to help it monitor what people are saying about the agency on various social media channels. And now, despite recently cancelling other proposed contracts, the agency has announced it has awarded the contract to software developer IB5k. Editor's Note: A previous version of this story noted the contract was for $182...
  • 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...
  • FDA Seeks to Determine how Consumers Find Health Information Online, Perceive Benefit-Risk

    Direct-to-consumer marketing is a topic of regular interest to regulators with the US Food and Drug Administration. At various times during the past several years, it has announced studies involving the use of composite scores in DTC advertising, the affect of DTC advertising on healthcare professionals , and corrective advertising resulting from improper DTC marketing. Now it's making some substantial changes to a DTC study first approved in 2011, according to docu...
  • Do They 'Like' Us? FDA Wants Tool to Better Assess its Impact on Social Media

    The US Food and Drug Administration (FDA) doesn't always seem like it's listening to its stakeholders. But if a recent sources-sought notice posted to the Federal Business Opportunities (FBO) website is any indication, it's listening a lot more closely than most people would realize. A hallmark of many businesses in the last few years has been the use of analytics tools to gauge the impact of various "campaigns," including on social media. For example, by using special p...
  • FDA Preparing to Devote more Resources to Social, Mobile Outreach

    The US Food and Drug Administration (FDA) is, first and foremost, a public health agency responsible for regulating the safety and efficacy of healthcare products. But central to that mission is how it communicates with the public about those products, something made even more complicated with the advent of new technologies. Background These difficulties are put on display in a new report just published by FDA, which notes that the last two decades have seen the develop...
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    RSS Comes to Regulatory Focus: One More Way You Can Follow Focus

    You spoke, and we listened. We're proud to unveil a brand new way to connect with Regulatory Focus : through RSS feeds. Regulatory Focus now has several RSS feeds you can subscribe to, depending on your needs: All Regulatory Focus Content Regulatory Focus News Latest News Regulatory Updates Regulatory Focus Features Regulatory Focus Departments It's the Law Perspective Quality and Compliance Science and Technology...
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    Legal Issues in Digital Pharmaceutical Communication in the EU--Part 3

    In March 2011, the European Commission launched a public consultation on an updated eHealth Action Plan for the period 2012-2020 1 , which had been called upon by the Council Conclusions on Safe and Efficient Healthcare through eHealth of December 2009 2 , and superseded the first plan adopted in 2004. Similarly, the US Food and Drug Administration (FDA) promotes the development of mobile medical apps that provide consumers and healthcare professionals with valuable he...
  • False Statements on Facebook Regarding FDA-Regulated Product Lead to Jail Time for Iowa Man

    Rarely does one person influence how the US Food and Drug Administration (FDA) looks at a company, but every so often one person comes along and-for better or worse-changes the agency's perspective. This article is about the latter of those two possibilities. Background An example of the former may well be Dinesh Thakur, who blew the whistle on deficient practices at Ranbaxy, practices for which the company has now paid hundreds of millions of dollars. But if that's ...