• Feature ArticlesFeature Articles

    A (Technologically Stunted) Ad/Promo Reviewer Looks at Techy Solutions to Regulatory Issues

    I thought I was technologically savvy; at any given moment, I was juggling an iPhone, laptop, Blackberry, Kindle, iPad and who knows what other piece of technology I didn't actually need. Then, to my surprise, I encountered other "popular" forms of technology of which I was completely unaware. For instance, when interviewing potential candidates at a recent conference, I was handed business cards printed on the back with little boxes containing Rorschach-like images. Afte...
  • Device Groups Say FDA Communication Guidance Gets Additional Information Letters Wrong

    Several entities within the medical device industry are calling attention to a provision within a recent draft guidance published by the US Food and Drug Administration (FDA) that they say offers little in the way of clarification and could potentially be a sticking point during complicated and contested review proceedings. Background In March 2013, FDA released a long-awaited guidance entitled Types of Communication During the Review of Medical Device Submissions . T...
  • Feature ArticlesFeature Articles

    IT Security for Regulatory Professionals

    • 06 December 2012
    In an age of smartphones, tablet computers and wireless communication, one could be forgiven for assuming the digital generation is risk aware and especially cautious when it comes to managing sensitive electronic data and information. On the contrary, much education is needed to create appropriate levels of risk awareness and encourage risk-averse behavior. Regulatory professionals have access to and manage highly sensitive and confidential company data and information...
  • Waxman Introduces New Bill to Require Data Collection, Monitoring by Antibiotics Industry

    • 18 October 2012
    Representative Henry Waxman (D-CA), the ranking member on the House Energy and Commerce Committee, is preparing to introduce legislation that would increase the amount of information required of manufacturers who produce antibiotics for use in animals. The legislation would require the US Food and Drug Administration (FDA), which recently released an advanced notice of public rulemaking on the topic of antibiotic monitoring and use, to "increase information on the am...
  • Government Investigators: FDA Must Assess Medical Devices for Hacking Risks

    Government oversight officials are sounding the alarm over what they say is the potential for US Food and Drug Administration-regulated medical devices to be hacked, saying FDA needs to establish new safeguards to ensure unguarded devices don't exhibit easily exploited vulnerabilities. The report, " FDA Should Expand Its Consideration of Information Security for Certain Types of Devices ," was authored by the Government Accountability Office (GAO), an investigative servi...
  • Group: FDA's Interpretation of FOIA Procedures Illegal

    The public health advocacy group Public Citizen is blasting the US Food and Drug Administration (FDA) for its application of the Freedom of Information Act (FOIA) , saying in a statement that the agency's actions violate both the "letter and spirit" of the law. FOIA , passed in 1966, has been dramatically expanded over the last half century to include numerous provisions requiring federal agencies to release documents relating to many internal decision-making proce...
  • EU Science Agency Calls for Experts, Information on Host of Medical Device Safety Issues

    The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published seven announcements calling for information and experts on a host of emerging and established regulatory issues related to several classes of medical devices. The 8 August announcements come in response to several requests that it update earlier scientific opinions or issue new ones where no earlier opinion exists. Nanomaterials and Metal-on-Metal Hip Imp...
  • Watermelon and Web-links Form Basis of Drug Promotion Complaint Against Swedish Company

    • 25 June 2012
    [ Editor's note: an earlier version of this story indicated the website was run by Quintiles. Quintiles is only the marketing representative of Swedish Orphan Biovitrum AB in the US, and was not responsible for the website. ] The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to Swedish Orphan Biovitrum AB for allegedly making misleading claims regarding the safety and efficacy of Kepivance (palifermin) on a w...
  • Disease-information Enhanced Advertisements May Be Misleading Consumers, Says FDA

    The US Food and Drug Administration (FDA) seems to be in favor of un-branded disease awareness commercials. In a Federal Register posting on 20 June, the agency says it is aware of research saying consumers find the advertisements both more helpful and less intrusive than branded product commercials, which is in line with the agency's goals to "encourage the communication of accurate health messages." What it's not supportive of, however, is when disease information is ...
  • Study Calls for Additional Regulation of Package Labeling

    To hear Laura Bix's analysis, it's a wonder more people aren't hurt each year by the medications they take. In a study published in the online medical journal The Public Library of Science: One , Bix, an associate professor at Michigan State University, and colleagues looked at how consumers analyze information presented on drug labels in the form of additional prescription drug warning labels (PWLs)-the small stickers on drug packaging imploring you to take heed of imp...
  • NIH Wants to Educate Children About Clinical Trials Using Video Games

    The National Institutes of Health (NIH) says it wants to better inform potential participants of clinical trials about the risks, benefits, and misconceptions surrounding clinical research. Unlike previous efforts involving websites, pamphlets and advertisements, however, it wants to employ something new: video games. In a Federal Register posting on 13 June, NIH said it was contracting with the New England Research Institute (NERI) to develop a video game on behalf of...
  • FDA Plans Major Overhaul of Recall Reporting

    The US Food and Drug Administration's (FDA) weekly enforcement reports, which detail product recalls and corrections taken during the week, are about to get a major overhaul according to an agency announcement. The agency last week reported in a little-noticed item within its enforcement report that it would be making changes to the way it updates its enforcement reports for pharmaceutical product recalls. The agency wrote at the time it intends to "modify the drug pro...