• Regulatory NewsRegulatory News

    Nutrition, Health and Disease Management, Advertising, Promotion, Labeling and a Preview of November's MDR, IVDR Update

    Feature articles over the past several weeks covered two main themes: nutrition, health and disease management and advertising, promotion, labeling. Articles highlighted nutrition's role in disease management; the impact of regulatory developments on dietary supplements; regulatory hurdles for medical food and the need for substantiating distinctive nutritional requirements; the role of post-market surveillance in ensuring dietary supplement safety; legal definitio...
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    Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods

    Feature articles over the past several weeks covered two main themes: global reimbursement strategies and advertising, labeling and marketing. Individual country profiles on England, France, Germany, Italy and Spain took a closer look at reimbursement. A candid interview with two leaders from the Alliance for Regenerative Medicine (ARM) provided insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell ther...
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    Health Technology Assessment, Reimbursement, Scientific Research, Risk Management, Generic Drug Legislation and a Preview of September

    The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in September. Feature articles over the past several weeks highlighted various global reimbursement strategies including integrated scientific advice, the regulatory significance of wearable technologies, prescription drug reimbursement issues in Canada and the harmonization of marketing, regulatory and reimbursement strategies for US medical devices. Ot...
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    Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July

    The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in July. By Gloria Hall Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars. Other articles covered the IT approaches to support the gap analysis and i...
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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...
  • 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...