• Feature ArticlesFeature Articles

    Cybersecurity, Supply Chain Security, Good Distribution Practices and FDA’s Drug Registration Process

    Feature articles in December highlighted: cybersecurity regulations the benefits of serialization software EU GDP guideline five years later an overview of the current Israeli regulatory system conflicts with separate drug approval in adults and children components of FDA’s drug registration process how to perform a GMP audit the benefits of visual data Securing the Supply Chain Over the past decade, there has been an enormous explosion of minute networked m...
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    Biosimilars, Consumer Advertising and Medical Device and In Vitro Diagnostic Regulations

    November feature articles covered: An Update on Biosimilars Global IVD Regulation and Changing Clinical Evidence Requirements Consumer Advertising and Medical Device Regulations Regulatory Information Management Regulatory Science Biosimilars and Regulatory Science Over the last 10 years, biosimilar acceptance has progressed significantly in Europe and the US although several organizations are advocating for more complete, accurate, transparent prescribing and ...
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    Making Regulatory Information Management (RIM) Transformation Work

    This interview discusses taking a “process-centric approach” to Regulatory Information Management (RIM) and is based on presentations given by two regulatory professionals, Nancy Allen, a senior director in Global Regulatory Affairs at Eli Lilly and Paula Hudson, global implementation lead for RIM Systems Process at Eli Lilly. Allen and Hudson were presenters at the Veeva R&D Summit held on 19 September 2018 in Philadelphia, PA. RAPS: What were Eli Lilly’s goals in imp...
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    Advertising, Promotion and Labeling, Accelerated Approval and Regulatory Science

    October feature articles covered the following topics: the changing advertising and promotion landscape labeling accelerated approval regulations for drugs and devices comparability bridging studies for combination products FDA resources regulatory science In January 2017, the release of two guidance documents shook the pharmaceutical advertising and promotional landscape and, consequently, affected the “risk tolerance” level of regulatory professionals. In “ The...
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    Benefit-Risk Management, Global Advertising, Promotion and Labeling Regulations and Regulatory Intelligence

    Feature articles over the past weeks have focused on the ability to assess and manage the benefit-risk profile of drugs, rules for updating prescription drug labels, off-label communications efforts, FDA’s role in regulating the advertising and promotion of prescription drugs, biologics and medical devices, the challenges of regulating mobile applications versus computers systems and recommendations for measuring regulatory compliance of complementary medicines. Researchi...
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    Risk Management, Policy Framework, EU MDR and EU IVDR, and Global Orphan Drug Regulations

    Feature articles over the past weeks have focused on risk management, the global regulatory framework, including next generation cancer vaccines, drug delivery combinations and pediatric plans, the latest on EU MDR and EU IVDR implementation and global orphan drug regulations. Risk Management Recognized drug safety and risk management expert Elaine Morrato discusses the intersection of emerging implementation science and regulatory science innovation and how together...
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    Nutrition in Health and Disease Management

    Over time, regulatory frameworks have evolved to protect consumers and patients. An unprecedented progression of demographics—including an aging society, noncommunicable chronic diseases, and transforming innovations in healthcare—pose challenges and provide potential opportunities. Action is needed to develop timely, appropriate and affordable healthcare solutions for patients and society. Policies and regulatory frameworks must also be fit-for-purpose to stimulate innov...
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    Innovative Technologies, 3D Printing, Accelerated Pathways, Biosimilars and an Update on Brazil

    Articles posted throughout June featured various innovative technologies, including the increased use of artificial intelligence in the healthcare industry and the challenges of adopting 3D printing or additive manufacturing to develop products in the pharmaceutical industry. Other articles focused on the FDA’s Emerging Technology Program, critical technologies for conducting global clinical trials, complexities of global accelerated pathways in EU, US and Japan, innovati...
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    Drug Reform, Expedited Pathways, Regenerative Medicine and Gene Therapy

    Articles posted throughout May included global opportunities and requirements for expedited pathways, a harmonized gene therapy model, drug shortage roadmap for the temporary importation of a prescription pharmaceutical and regenerative medicine policy framework. Other articles covered global regulatory timelines for drug applications and regulatory reform, the impact of FDA's change in policy on voting pattern and MHRA's Promising Innovative Medicines (PIM) designation a...
  • Global Opportunities and Requirements for Expedited Pathways

    This interview features insight from two leading industry executives, Bridget Heelan and Bhardwaj (Bob) Desai , on the complexities of expedited pathways in the major markets of the US, EU and Japan and highlights expedited pathways with regard to significant benefit, clinical trials design and data, surrogate end points, orphan drugs, reimbursement and potential drawbacks to expedited pathways. Introduction Because of increased research and drug development ...
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    Expanded Access Policy Requirements, Orphan Drug Legislation and Gene Therapy Regulatory Challenges

    Articles posted throughout April include a look at how to comply with new expanded access requirements and programs, expanded access programs for medical devices, orphan drugs, regulatory and economic challenges for gene therapies, re-designing regulatory capabilities to improve operational efficiency and a review of US and EU veterinary device regulations. Expanded Access Policy Requirements Regulatory manager, Matt Medlin and regulatory intelligence expert, Meredit...
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    Regulatory Operations, Resources and eCTD Benefits

    Articles posted throughout March included in-depth coverage on the use of electronic Common Technical Documents (eCTDS), regulatory resources and operations, FDA's citizen petition process and ASEAN harmonization efforts. eCTD Update The deadline after which all Investigational New Drug Applications (INDs), Drug Master Files (DMFs) and their amendments will be required to be both in Common Technical Document (CTD) format and submitted electronically (collectively called...