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  • Regulatory NewsRegulatory News

    FDA Looking for a Leader for its New Device Testing Division

    The US Food and Drug Administration (FDA) is on the hunt for a new leader for its device center's newly formed Division of Biology, Chemistry and Materials Science (DBCMS). The new division, housed within the Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Laboratories (OSEL), is primarily concerned with how medical devices physically interact with patients. For example, its staff will be assessing devices for biocompatibility, biolo...
  • Regulatory NewsRegulatory News

    FDA Unveils Pilot Program Aimed at Accelerating Approvals of New Medical Devices

    The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals. Background Regulators have long been interested in making sure that tools and measures used during the medical device development process are validated -- that is, proper for use and fit for purpose within a specific context. Many clinical trials are ultimately scrapped...
  • 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...
  • Regulatory NewsRegulatory News

    On the Heels of FDA Investments, PhRMA Funds Regulatory Science Initiative

    In recent years, the US Food and Drug Administration (FDA) has made substantial investments in regulatory science initiatives, spending millions on research, establishing new academic programs, and partnering with dozens of institutions in the pursuit of new ways to bring safe and effective drugs to market more quickly. But the agency isn't the only one interested in advancing regulatory science. In an announcement this week, the influential pharmaceutical industr...
  • Regulatory NewsRegulatory News

    FDA Plans to Spend as Much as $50M on Regulatory Science, With Focus on Generics

    The US Food and Drug Administration (FDA) has released its latest " Broad Agency Announcement " detailing the areas to which it hopes to direct funding in the coming year in order to solve or alleviate some of its most pressing regulatory needs. Like FDA's 2013 Broad Agency Announcement, the 2014 announcement says FDA is prepared to spend—"subject to congressional appropriations"—as much as $50 million on meeting nine overarching goals and dozens of sub-level interests. ...
  • Feature ArticlesFeature Articles

    Sleep—Still a Mystery!

    • 07 May 2014
    Most people spend a full third of their lives asleep, yet most of us do not have the faintest idea what sleep does to our bodies and our brains. Sleep remains one of the secrets of science. 1 However, there is ample evidence indicating that difficulty in falling asleep and non-restorative sleep are associated with the risk of cardiovascular disease in adults and young children. Statistically, after adjusting for lifestyle factors, age and chronic conditions, researchers ...
  • Two New Centers of Regulatory Science Excellence Launched by FDA

    The US Food and Drug Administration (FDA) is throwing its support behind two new scientific programs intended to advance the state of regulatory science in the US. Under an agreement announced on 5 May 2014, Johns Hopkins University and the University of California at San Francisco/Stanford University will join two other universities working with FDA as "Centers of Excellence in Regulatory Science and Innovation" (CERSI). The programs are part of an effort by FDA to bri...
  • Legislators Seek New Regulatory Tools, Framework for Regenerative Medicine

    New legislation introduced in the House of Representatives this week seeks to develop a comprehensive framework capable of allowing the "rapid approval" of regenerative medicine products by the US Food and Drug Administration (FDA). While the bill, the Regenerative Medicine Promotion Act (RMPA) of 2014 , does not define the term "Regenerative medicine," it is defined by the National Institutes of Health as, "the process of creating living, functional tissues to repair...
  • 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...