• Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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 ...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    Regulatory Intelligence Trends, Risk Management, Brexit and Medical Device Legislation

    Articles posted throughout February included a wide variety of topics, including regulatory intelligence, document legalization, prescription to non-prescription switches in Canada and Brexit preparation. Other articles covered medical device risk management, emerging technologies in FDA drug approval process and regulation of pharmaceutical products in Ethiopia. " Regulatory Intelligence: 2017 FDA Review and Trends to Watch ," by principal consultant Meredith Brown-Tut...
  • Feature ArticlesFeature Articles

    January Features Examine the Latest on Regulatory Intelligence, Policy and Trends

    How can regulatory trends be identified? What are best practices for commenting on new or revised regulatory documents? And, what's going on with the EU revisions to medical device regulatory requirements? January's feature articles are alive with answers to these thorny questions and some of the most experienced regulatory professionals have provided their best advice. Pharmacist and attorney, Benjamin Chacko , who served as regulatory counsel for US FDA, looks back at...
  • Feature ArticlesFeature Articles

    Responding to the Challenges of Meeting the New EU Regulations Requirements: Insight from Three Global Regulatory Executives

    This article describes efforts to prepare Cook Medical and its partners for full implementation of European Union Medical Device Regulations in (EU-MDR) in 2020. It is based on interviews with Cook executives Jennifer Kerr, president of Cook Research Incorporated (CRI), April Lavender, senior vice president of regulatory affairs for Cook Medical, and Sinead Quaid, director, global regulatory affairs, at Cook Ireland. Introduction With the European Parliament's final app...
  • 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...