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  • RAPS' LatestRAPS' Latest

    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...
  • RAPS' LatestRAPS' Latest

    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...
  • RAPS' LatestRAPS' Latest

    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 Other articles explored key elements of FDA's latest draft guidance o...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...
  • Regulatory NewsRegulatory News

    Global Regulatory Strategy, Draft CFDA Data Integrity Guidance and a Preview of November

    Feature articles in October explored global regulatory strategy, including how to overcome the lack of standardization with Regulated Information Management (RIM), the best strategy for global submissions in this changing regulatory environment, trends changing the landscape of global regulatory submissions and the critically important oversight of regulatory professionals to ensure compliance of the product with legislation in the regions where the product is intended to...
  • Feature ArticlesFeature Articles

    Changing Times of Advertising and Promotion, Hot Topics and a Preview of October

    Feature articles in September take a closer look at the evolution of prescription drug and medical device advertising and promotion, from the history that helped shaped the regulations to modern day case law involving the First Amendment. Along the way, we have noted a shift in FDA's enforcement with respect to their areas of focus and frequency of enforcement action. Even though the recent enforcement landscape has been relatively quiet, regulatory professionals must rem...
  • Regulatory NewsRegulatory News

    Nutrition, Health and Disease Management, Hot Topics and a Preview of September

    New Food Regulatory Paradigms: The Right Paths for Nutrition, Health and Disease Management The August collection of feature articles for Regulatory Focus explores the changing healthcare paradigms when food (health) and drug (disease) systems, once separate silos, are now moving closer together. This creates new opportunities, yet also gray zones, making historic pharmaceutical and nutrition "models" prone to be revisited. Leading global experts in their respective fi...
  • Feature ArticlesFeature Articles

    August Feature Articles Highlight Food Regulatory Paradigms: the Right Paths for Nutrition, Health and Disease Management

    Over time, the regulatory framework has evolved and continues to protect consumers and patients. However, with the unprecedented changes in demographics and advances in healthcare, it is even more important for regulatory professionals to continue to deliver timely, appropriate and affordable healthcare solutions to patients and society. And this changing healthcare paradigm with food (health) and drug (disease) systems moving closer together has created possible new oppo...
  • Regulatory NewsRegulatory News

    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 ...