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  • Regulatory NewsRegulatory News

    FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation

    The US Food and Drug Administration (FDA) has released a new draft guidance document on social media focused on how companies can correct blatant misinformation contained on the Internet and social media channels, long a source of frustration for FDA-regulated companies. 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 20...
  • 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...
  • Regulatory NewsRegulatory News

    FDA to Provide Guidance on Use of Economic Information, Responses to Unsolicited Requests

    US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information. Background The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guida...
  • 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 Now the life science industry is weighing in on that draft guidance, calling for changes and clarifications.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...
  • Once Again, FDA Seeks to Leverage Social Media to Uncover Adverse Events and Public Sentiment

    The US Food and Drug Administration (FDA) is once again forging ahead with plans to monitor social media networks more closely in an attempt to keep up with problems affecting FDA-regulated products like drugs and medical devices. FDA has issued similar plans twice in the last year, including a September 2013 announcement in which it pledged to spend up to $182,000 on a social media tool to shape and monitor social and Internet communications, and a more general not...
  • FDA Finalizes Guidance on 'Dear Healthcare Provider' Letters

    The US Food and Drug Administration (FDA) has released a final guidance that aims to clarify the agency's requirements for information contained within "Dear Healthcare Provider" (DHCP) letters. Background The letters-so-named because they often begin with that exact salutation-are usually bulk mailings sent out by a manufacturer when it has been made aware of a serious problem with a drug or biologic, or when there is a need to provide updated information to the health...
  • 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...