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  • Regulatory NewsRegulatory News

    EMA Board Signs Off on New Medicines Web Portal

    The European Medicines Agency’s (EMA) management board on Monday announced that it’s given the go-ahead for a new European medicines web portal, which will look to provide wider access to free, reliable and unbiased information on all medicines authorized in the EU. The portal, which will replace EMA’s online interface EudraPharm , will offer updates on everything from clinical trial information to adverse drug events. Background 2010 pharmacovigilance legislation, ...
  • Regulatory NewsRegulatory News

    Association Calls on FDA to Regulate Online Vision Exam as Medical Device

    The American Optometric Association (AOA) has submitted a complaint to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) over an online eye exam that may not accurately generate prescriptions for eyeglasses or contact lenses. The complaint is directed at Opternative , which is marketing its online eye exam directly to consumers and claiming that it can provide a prescription for eyeglasses or contact lenses “as accurate as an i...
  • RAPS' LatestRAPS' Latest

    Tell RAPS How to Get Organized

    Sometimes, when you look for information on a website, the intuitive way topics are organized leads you to exactly what you were searching for in mere moments. Other times, information is not where you expect it to be, menus are confusing and when you finally find the page you were looking for, it’s not as helpful as it could be. RAPS is trying to make navigating its website, RAPS.org , much more like the former experience and much less like the latter. As part ...
  • RAPS' LatestRAPS' Latest

    RAPS Wants to Know How to Better Help You Survey Deadline: 27 March

    • 24 March 2015
    • By
    RAPS has launched a new survey as part of its effort to improve the RAPS.org website and make it the best source of information and resources for regulatory professionals around the world. You have until Friday, 27 March to take this brief survey, which is open to everyone in the RAPS community—RAPS members and nonmembers alike. RAPS’ ultimate goal is to provide more valuable content online and make RAPS.org easier to use, so the questions focus on the needs and pr...
  • Regulatory NewsRegulatory News

    MHRA Joins other UK Agencies on Consolidated Website

    The UK’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) this week announced major changes to its website meant to incorporate it more thoroughly into the UK government's main website. MHRA announced its plans to move from the old website (www.mrha.gov.uk) to www.gov.uk/mhra in April 2014. The new website launched on 28 January 2015 with a design that incorporates feedback from users on how they use the MHRA website and the Drug Safety Update system. Diffe...
  • FDA Website Knockoff Markets Non-FDA-Approved Products

    In the mid-1990s, when "The Internet" was still in its infancy and government institutions were just beginning to develop an online presence, the world got perhaps its most notable look at how some purveyors will seek to profit off of website confusion. Twenty years later, though, it's still a problem, including for US healthcare product regulators. Background The problem then, as now, is that many people aren't always sure about which domain name suffix- .com, .org, .g...
  • In Rare Warning Letter, FDA Hits Company for Making Unapproved Claims About Device

    The US Food and Drug Administration (FDA) this week sent a rare Warning Letter to a medical device manufacturer chiding it for promoting its product for a purpose not approved by the agency. The 26 February 2014 Warning Letter to NeoMedix Corporation references the company's Trabectome High Frequency Generator, a device cleared earlier for use with compatible electrosurgical instruments in low-power microsurgical applications for the removal, destruction and coagulation...
  • FDA Unveils New Mobile-Friendly Website Design and New Features

    Visit the US Food and Drug Administration's (FDA) website today, and you're likely to see some changes. Visit it on your smartphone, however, and you're likely to understand just how big the changes really are. Changes to FDA's website were first noticed early on 18 November 2013 by Regulatory Focus , and were confirmed by multiple FDA representatives as being part of a larger overhaul. At present, the website appears to be undergoing a methodical update affecting var...
  • Feature ArticlesFeature Articles

    Industry Strategies for Linking Disease Awareness Websites to Product Promotions

    • 22 October 2013
    • By
    The US Food and Drug Administration (FDA) has been notoriously silent on the question of the appropriate use of hyperlinks in the context of brand promotion. Dating back to its 1996 hearings on the Internet, FDA has been asking when the use of hyperlinks is appropriate, and in the 2009 FDA hearings on social media and the Internet, the question was restated by FDA. 1 However, guidance from the agency on this issue has not been forthcoming. In its absence, certain industr...
  • EMA in Midst of Website Overhaul, Calls for Industry Assistance

    The last decade has seen an increasing shift into digital forms of communication, submission and information in the regulatory affairs space. Sponsors can now submit applications and submit updates to regulators electronically, and-perhaps most importantly-find the regulations and guidance documents they need online instead of in a library or legislative building. But as those layers have built over time, it has become exceedingly difficult for a sponsor to find the exact...
  • GHTF Says Final Goodbyes, Shutters Website

    So long, Global Harmonization Task Force (GHTF). The global medical device harmonization body has finally disbanded, leaving its unfinished work to the International Medical Device Regulators Forum (IMDRF), a successor organization comprised of officials from regulatory agencies-not industry-around the world. The organization had been a mainstay among the regulatory harmonization movement. Formed in 1992 by EU, US, Japanese, Australian and Canadian regulatory and industr...
  • UPDATED: FDA Withdraws Final Rule After Receiving 'Significant Adverse Comment'

    • 26 June 2012
    • By
    Sometimes it takes just a single powerful argument to derail an intended final rule. The US Food and Drug Administration (FDA) announced on 27 June its withdrawal of a final rule as the result of a "significant adverse comment." The agency did not elaborate on the comment or its significance, but the intended final rule was published on 23 March 2012. Entitled, "Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agen...