• Regulatory NewsRegulatory News

    Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds

    Two safety communications issued by the US Food and Drug Administration (FDA) had different impacts on the use of surgical mesh to treat pelvic organ prolapse (POP), according to a recent study appearing in JAMA Internal Medicine . The first look at the use of surgical mesh in New York between 2008 and 2011 found that use actually increased after FDA's first safety communication, from 21% of all procedures in 2008 to 30% in 2011. However, the use of surgical mesh later ...
  • Regulatory NewsRegulatory News

    The Biggest Challenge for Regulators That No One's Talking About: Translation

    Regulators have long been concerned with the safety, efficacy and quality of the products they regulate. Now they have a new concern to think about: language. South Korea's healthcare products regulator is learning that lesson this week after being called out by The Korea Times for failing to keep its English-language website up to date. But as a review by Regulatory Focus shows, it's hardly the only regulator struggling to translate its documents in a timely manner...
  • Regulatory NewsRegulatory News

    European Industry Group Calls for Drug Shortage Reporting Standards

    A group of four pharmaceutical industry associations in Europe is proposing a set of guidelines meant to help European National Competent Authorities (NCAs) and the European Medicines Agency (EMA) alleviate drug shortages through better communication. In its report, the group recommends a set of harmonized standards for how drug shortages caused by quality or manufacturing issues are communicated to relevant authorities. Background Currently, marketing authorization ...
  • Regulatory NewsRegulatory News

    FDA Wants Input on How to Improve Clinical Trials Process for Industry

    The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process. In an announcement in the Federal Register on 28 October 2014, FDA said it had established a docket at regulations.gov to allow it to receive comments from industry, the public and other organizations interested in formulating "best practices for communication between FDA and investigational new drug appl...
  • Regulatory NewsRegulatory News

    Researchers Say FDA Should Take More Active Role in Disseminating Drug Safety Warnings

    In addition to approving products and making sure bad ones never make it to market, an indispensable role of healthcare product regulators is warning consumers and healthcare professionals about new risks associated with already-approved healthcare products. The US Food and Drug Administration (FDA) regularly sends out such warnings, generally known as drug safety communications , and as of 27 June 2014 had already issued 12 warnings in 2014—an average of two per ...
  • CDRH, CBER Finalize Medical Device Review Communication Guidance

    A new guidance document released by the US Food and Drug Administration (FDA) is intended to clarify the types of communication used by FDA and industry during the review of medical device submissions. Those submissions include premarket applications (PMAs), PMA supplements, biologic license applications (BLAs), BLA supplements and premarket notifications [510(k)s]. Background The guidance is intended to reflect changes undertaken by the agency under two pieces of legi...
  • FDA Expresses Interest in Increasing Impact, Reach of Safety Warnings

    The US Food and Drug Administration (FDA) has announced that it will soon convene an advisory committee to discuss whether changes are needed to its " Consumer Updates " in order to make them more impactful and useful to consumers. Background At present, consumer updates are used by the agency to address important or pressing topics of public health interest. In recent weeks, FDA has issued Consumer Updates for topics including misbranded dietary supplements, the limita...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    Regulatory Issues in Digital Pharmaceutical Communications in the EU--Part 1

    • 25 April 2013
    The use of eHealth systems and services-defined as healthcare practice using the Internet-offers great potential to enhance patient safety by avoiding medical errors and improving communications, while reducing costs and inefficiencies in areas such as record keeping. 1 Because of this potential to improve health systems, the use of eHealth technology to aid in medical diagnosis and treatment and support pharmaceutical communication will likely become increasingly commo...
  • New Regulatory Tools Requested to Study Messaging of Regulators, Industry

    How does a regulatory agency best communicate and regulate essential messaging to stakeholders on a continual basis without being ignored? The US Food and Drug Administration (FDA) isn't necessarily sure, either, and is looking to the private sector for answers. Writing on the Federal Business Opportunities website on 4 January 2013, FDA released an addendum to an earlier contact solicitation in which it sought the expertise of an outside firm to assist it in advancing...
  • Report: Clashes Between White House, FDA Frequent

    A report in The New York Times indicates the US Food and Drug Administration (FDA) and the Obama Administration are frequently at odds-partially the result of poor communication and partially the result of poor political optics-which has caused significant amounts of tension between the two government bodies. The report notes numerous instances where the Administration and FDA have clashed, including the banning of Primatene asthma inhalers, Health and Human Services S...
  • FDA Releases New Safety Communication Strategy

    The US Food and Drug Administration (FDA) released draft guidance on 8 March on how it intends to communicate with the public about drug safety issues, including important topics and emerging information. "The revised guidance describes the Center for Drug Evaluation and Research's (CDER's) single, standardized format for electronic drug safety communications about marketed drugs and provides information about the Center for Biologics Evaluation and Research's (CBER's) s...