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    Regulatory Intelligence Communication for Business Impact

    This article focuses on maximizing Regulatory Intelligence (RI) in response to specific stakeholder requests and offers best practices recommendations for RI communication. The authors provide an overview of information delivery methods and their applicability and present general considerations for communicating RI information by spreadsheets, text documents, slide presentations, strategy reports and competitive intelligence reports. They also highlight the use of due dili...
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    FDA’s Oncology Clinical Trial Makeover

    Recent communication by FDA affirming its support for modernized oncology clinical trial conduct, manifested in four guidance documents addressing adolescents, conduct of First-in-Human (FIH) expansion cohorts, the use of placebo/maintenance of the study blind and master protocols. This article provides an overview of new FDA guidances related to oncology drug development and a review of pilot programs aiding faster access to new, innovative treatments without increasing r...
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    Proactive Regulatory Intelligence Communication

    This article focuses on regulatory intelligence communication approaches for medium to large companies and highlights the advantages and disadvantages of each. Introduction To stay current with the rapidly changing landscape, regulatory affairs professionals must monitor and identify pertinent regulatory information on a continual basis. This information must then be analyzed and interpreted for the application and implications to team projects, the organization and pot...
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    China Regulatory Reform: An Update on Review Timelines and Drug Lag

    This article provides three case studies with an assessment of the impact of the regulatory changes and insight into the importance of including China in a global strategy for clinical development and drug registration. Introduction China has implemented a series of regulatory changes and improvements through a comprehensive regulatory reform starting in August 2015. The largely shortened new drug review timeline provides one of the biggest impacts for the pharmaceuti...
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    FDA Regenerative Medicine Policy Framework and Advanced Therapy Designation

    This article discusses the policy framework established by the US Food and Drug Administration (FDA) for the regulation of regenerative medicine and advanced therapies. The four guidance documents supporting regenerative medicine regulation are summarized against the background of FDA's regulation of human cells, tissues and cellular and tissue-based products. Introduction In November 2017, FDA published a comprehensive Regenerative Medicine Policy Framework to stimulat...