• 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 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 developme...
  • 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...
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    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...
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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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    Regulatory Career Paths and Progression, Resources and Training, FDA Inspections, Cleaning Validation and a Preview of August

    Feature articles over the past several weeks highlighted regulatory affairs as a profession, including careers in regulatory advertising and promotion, possible pathways and career progression and resources and training for regulatory professionals. Other articles covered various types of inspections conducted by FDA and processes for cleaning validation in the pharmaceutical industry. Regulatory Careers Faderan's exclusive interview with the president of Cook Researc...
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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...