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    Theoretical Perspective of Technology for Regulatory Science: Part 2

    Regulatory science is the discipline that oversees, creates and implements innovation for global health needs. Yet, no philosophy of technology exists for regulatory science. This article attempts to fill that gap and focuses on problem-solving tools or 'global skills'. Introduction Part one introduced the concept of a regulatory science philosophy of technology. 1 Figure 1 depicts a regulatory science key representing the means to unlock new drug and device outcome...
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    What are biosimilars and why are they important?

    This article provides an overview of biosimilars and explains their benefits, similarities to “reference” biologics, clinical applications and recent regulatory challenges. It is intended to provide a top-level introduction to regulatory professionals who have a limited awareness of or are new to biosimilars. Introduction Biosimilar medicines are no novelty, they have been around for more than a decade. The first biosimilar approved in Europe was Sandoz’s somatotropin b...
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    Regulatory Progress of Biosimilars: An Update

    This article discusses issues related to the development and marketing of biosimilars aimed at having the same therapeutic effects as biotherapeutics. The author covers biosimilar approvals in Europe and the US, comparability studies, labeling issues, interchangeability and postmarketing issues. Over the last 10 years, biosimilar acceptance has progressed significantly both in the EU and US, although the author notes several organizations advocating for more complete, acc...
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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...
  • Feature ArticlesFeature Articles

    Theoretical Perspectives of Technology for Regulatory Science: Part 1

    Regulatory science is the discipline of overseeing, creating and implementing innovation for global health needs. Part one of this two-part article provides a foundational regulatory philosophy of technology and illustrates the purpose of regulatory science and tools practitioners can use to challenge current constructs on medical availability and drug/device development approval processes. Introduction Regulatory science is an emerging discipline used in the pharmaceut...
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    FDA’s Small Business and Industry Assistance Program: A Helping Hand to Small Pharma

    This article discusses services and programs offered by the US Food and Drug Administration (FDA), including a Small Business and Industry Assistance (SBIA) Program to help both large and small pharmaceutical companies in their journey through regulatory hoops and into the marketplace. Services include conferences, Webinars, tutorials, other online information and various communications services. Introduction Taking a drug product from proof-of-concept to the consumer’s...
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    RAPS Workshop Proceedings: Comparability Bridging Studies for Combination Products

    This article, based on a RAPS combination products workshop, discusses comparability, bridging, combination products and human factors and highlights participant presentations given during the workshop. The authors cover the FDA panel discussion, group exercises, case study experiences and considerations regarding bridging studies that have already been implemented into the study plans of sponsors in attendance. Those studies have the potential of being incorporated into ...
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    21st Century Cures Act and Acceleration of Device Approval

    This article discusses two critical provisions of the law meant to accelerate FDA approval of medical devices. It explains the benefits of the provisions, which have been criticized by consumer advocates in the past. Introduction It has been almost two years since the 21st Century Cures Act was signed into law, promising to modernize and accelerate the approval process for medical devices and other medical products. The US Food and Drug Administration (FDA) has attrib...
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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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    Regulatory Considerations and Best Practices for Promoting an Accelerated Approval Product

    This article discusses processes for the successful promotion of an accelerated approval product under FDA’s 1992 Accelerated Approval Program for drugs under 21 CFR Part 314 Subpart H and for biologics under 21 CFR Part 601 Subpart E. The author offers advice for working with the company’s commercial team and FDA’s Office of Prescription Drug Promotion (OPDP) reviewers and covers considerations for label updates to a multi-indicated accelerated approval product and consi...
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    Optimize Labeling and Advertising Outcomes through Targeted Subject-Matter Expertise

    This article discusses the importance of pharmaceutical labeling in terms of the strategies employed by labeling and advertising and promotions professionals and the benefits of working collaboratively. The authors address the usefulness of having teams of individuals from various backgrounds employing a variety of skill sets, all in the interest of launching a successful product with the enclosed packaging comprised of accurate and consistent information expressed clearl...
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    The Changing Regulatory Landscape of Advertising and Promotion

    This article provides two hypothetical “case studies“ demonstrating the impact of two recent FDA guidances for promotional communications that have the potential to change the US landscape of pharmaceutical regulatory advertising and promotion. The authors conclude that if regulatory professionals do ‘the right things,’ higher standards set forth by FDA in the new guidances will elevate the quality of pharmaceutical promotional communications to a ‘truthful and non-mislea...