• Feature ArticlesFeature Articles

    What Is 'Regulatory Intelligence?'

    This article provides an overview of regulatory intelligence, including identifying sources, using tools for gathering information, and the importance of recognizing copyright restrictions . Regulatory intelligence is the regulatory information you have been asked to gather and provide regarding topics of importance to your audience. For example, you may be asked to inform your company of any medical device-related items in the Federal Register or of FDA warning or un...
  • Regulatory NewsRegulatory News

    In Focus: The Top News Stories from 2015

    For RAPS’ Regulatory Focus , 2015 might simply be called: The Year of the Explainer. With major legislation altering the inner workings of the US Food and Drug Administration (FDA), as well as new priority review voucher programs coming to fruition, RAPS’ reader interest has been spiking for longer, more in-depth articles. Without further ado, here are the top most-read articles in 2015 based on traffic statistics: 9. After Three-Year Delay, FDA Finalizes Guidance Do...
  • Regulatory NewsRegulatory News

    Researchers Question Consistency of FDA’s Use of Surrogate Endpoints for Drug Approvals

    The US Food and Drug Administration (FDA) is not consistent with its use of surrogate endpoints in assessing the risks and benefits of treatments for some diseases, making it difficult to assess the treatments' actual clinical effects on outcomes important to patients, according to researchers from Johns Hopkins. The researchers came to this conclusion after evaluating 58 FDA drugs approved between 2003 and 2012 for chronic obstructive pulmonary disease (COPD), Type 1 an...
  • Regulatory NewsRegulatory News

    FDA to its Scientists: Feel Free to Engage on Social Media

    The US Food and Drug Administration (FDA) is now encouraging its employees to use social media in a personal capacity, particularly for sharing information that may benefit public health, as long as employees make clear that their opinions aren’t the views of the agency. The new policy, released last week, clarifies that employees do not need to obtain permission or approval from FDA supervisors or agency management to use social media in a personal capacity, although “e...
  • Feature ArticlesFeature Articles

    FDA Social Media Guidance–Lessons Learned from the Comment Period

    This article reviews and summarizes public comments on FDA's two draft social media guidance documents. In the past, traditional drug and device promotion came in the form of paper collaterals–sales aids, booth panels, slim jims* and the like. As we entered the internet age, companies found new avenues to get their product promotional messages out. Broadly defined as "social media," new forms of product communication now include interactive websites with sharing capabi...
  • Regulatory NewsRegulatory News

    CDRH Unveils Top Regulatory Science Priorities for 2016

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday. The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, eff...
  • Feature ArticlesFeature Articles

    Social Media: Changing the Rules for Regulatory Professionals

    This article discusses social media's role in the changing regulatory landscape and how regulatory professionals must evolve to ensure compliance with FDA requirements specific to the medical device field. As social media rapidly evolves via the internet, digital media platforms, new technologies and mobile applications enhancing the marketers' ability to create and deliver more personalized, segmented solutions to medical device users, regulatory professionals also ne...
  • Regulatory NewsRegulatory News

    FDA Science Board Calls on Agency to Find New Ways to Stimulate Biomedical Innovation

    The US Food and Drug Administration (FDA) has made “significant strides” in strengthening its scientific capabilities, though there is still some concern about the agency’s ability to support and stimulate biomedical innovation, according to a new report from a subcommittee of FDA’s Science Board. Background Six years after a 2007 report from the Science Board -- which, among other findings, called attention to FDA’s “weak scientific base and inadequate scientific wor...
  • Regulatory NewsRegulatory News

    Eight Years on, FDA Celebrates its Scientific Advancement

    Last week, the US Food and Drug Administration announced the release of a new report, FDA Science Moving Forward, showcasing the agency's scientific advancements since 2007. Major Changes Since 2007                                                                                  In 2007, FDA's Science Board released a report, FDA Science and Mission at Risk, which predicted that "rapid developments" in emerging scientific disciplines such as genomics, personalized ...
  • Regulatory NewsRegulatory News

    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
  • Regulatory NewsRegulatory News

    The First Quarter in Focus: Our Top 10 Stories of 2015 (So Far)

    It's already been a busy, busy year here at Regulatory Focus. During the first quarter alone, more than a quarter million of you have read more than half a million of our articles—a new record for Focus , and hopefully a testament to the value of the content we're producing on a daily basis. But which articles have attracted your collective attention the most? Read on to discover the top 10 articles in Focus so far this year. The Top 10 10.) FDA Launches New Drug ...
  • Feature ArticlesFeature Articles

    FDA’s Expedited Programs for Serious Conditions: An Overview

    For some serious or life-threatening diseases, few therapeutic options exist. Once a promising therapy is discovered, establishing its clinical benefit and safety profile is necessary but can be time consuming. Standard drug development programs involve formulating and manufacturing the drug product, characterizing the new drug, gathering adequate evidence on its performance, evaluating the safety risks and confirming the effects observed in the early clinical trial...