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    Global Harmonization Initiatives, FDA's User Fee Programs, Pediatric Legislation, Conditional Approvals, Quality Certificates and a Preview of June

    Feature articles over the past several weeks have highlighted various global harmonization initiatives, including the benefits of a new regulatory tool for improving operational flexibility when changes are introduced post-approval and progress with FDA's and EMA's pediatric regulatory activities. Other articles presented changes to and the industry impact of PDUFA, MDUFA and GDUFA , regulatory pathways to expedite the review of new drugs and the electronic Common Tech...
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    Biosimilars, 21st Century Cures Act, Clinical Trial Regulations, PDUFA, Global Regulatory Strategy and a Preview of May

    The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in May. Feature articles over the past several weeks have highlighted biosimilar intellectual property issues and key strategies being adopted by the innovator companies. Other articles covered regulatory changes impacting how premarket applications for combination products will be reviewed by FDA, aspects of the revised European clinical trial regulatio...
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    Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April

    The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in April. Feature articles over the past several weeks have highlighted regulatory intelligence tools, the importance of collaboration between commercial and regulatory functions, regulatory activities for establishing a joint venture in Japan and successful strategies for outsourcing. Other articles explored key elements of FDA's latest draft guidance o...
  • Feature ArticlesFeature Articles

    Global Regulatory Developments in Cell and Gene Therapy, Drug Manufacturing Inspections, Regulatory Intelligence Tools and a Preview of March

    Feature articles over the past several weeks have highlighted the challenges associated with the development of advanced therapy medicinal products, the evolution, potential uses and regulatory aspects of gene therapy, key points of international drug manufacturing inspections published in a new electronic journal by the Chinese Center of Food and Drug Inspection (CFDI) and the relevance of four draft guidances released by the China Food and Drug Administration (CFDA) r...
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    Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February

    The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in February. By Gloria Hall Over the past several weeks, feature articles presented the critical role of regulatory strategy and intelligence in the drug development process, sources for global regulatory precedent, information requirements for an investigational new drug application, benefits of a global web-based information management system, the re...
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    Quality and Compliance, Regulatory Research, Policy Issues and a Preview of December

    The following is a summary of feature articles posted throughout November with links and a preview of what's to come in December. Feature articles in November presented common misconceptions about quality control and quality assurance, the importance of developing a robust quality management system, process validation, the appropriate response time for FDA warning letters, regulations for prescription drug advertising, the impact of the 2016 revision of the ISO 13485 s...
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    Regulatory Focus Features Recap: July 2016

    Feature articles for July focused on managing regulatory information and systems and eCTD submissions. The regulatory industry is being challenged by the increasing complexity and rate of change associated with compliance related requirements, while also focusing on improving the efficiency of operations across the enterprise. For regulatory professionals, effective management of information and content is critical to managing interactions with health authorities on a ...
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    Walking the Digital Tight-Rope

    On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media. Most likely, you are currently reading this on your iPad, smart phone or computer screen as are the majority of people seeking information in this digital-age. To align with current user-practices, Regulatory Focus magazine moved to a completely digital format in 2012. Along the same vein,...
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    Call for Authors: We're Seeking Your Expertise

    • 20 March 2015
    Looking to expand your career by writing in-depth analyses on regulatory healthcare topics? Then Regulatory Focus wants you. The flagship publication of RAPS, Regulatory Focus is looking for both experienced authors and those new to publishing to write on themes selected by our Board of Editors for their usefulness to healthcare regulatory professionals. Topics cut across the full spectrum of healthcare products—drugs, medical devices, biologics, biotechn...
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    Happy Holidays, and Thank You

    • 19 December 2014
    Regulatory Focus is going on Holiday and will not publish between 20 December 2014 and 5 January 2014. We look forward to again providing you with regulatory news, analysis and intelligence in the new year. Before we go, we just have one thing to say: Thank you. Thank you for your continued readership and insights. Focus would be nothing without its readers, and your tips and help have allowed us grow, improve and continue to provide valuable content to regulatory p...
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    Introducing Some New Voices (and Changes) Here at Regulatory Focus

    If you've been keeping close track of Regulatory Focus over the last few months, you've probably already noticed some new names in article bylines. Focus has been teaming up with several trusted content providers to offer you unparalleled access to breaking news, unique data-based insights and regulatory events. In addition to RegLink , which has long provided us with hard-to-find information on global regulatory developments, we're pleased to now offer news from:...
  • Regulatory NewsRegulatory News

    Reintroducing Regulatory Focus: A New Look With New Features

    If you haven't already noticed, Regulatory Focus has a brand new look. What may not be so obvious are some of the changes throughout the Focus website—changes that should make for a more enjoyable and interactive experience for readers. The first major change has to do with how the site works on devices. The site is now built using "responsive design" elements , which means that it will automatically scale to whatever window size or device you're viewing it on....