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Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations
The United States Food and Drug Administration and the European Medicines Agency (EMA) each have programs to expedite development of products...
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The roles of cellular protease interactions in viral infections and programmed cell death: a lesson learned from the SARS-CoV-2 outbreak and COVID-19 pandemic
The unprecedented pandemic of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), which leads to COVID-19, is threatening global health....
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Aiding the Adoption of Master Protocols by Optimizing Patient Engagement
Master protocols (MPs) are an important addition to the clinical trial repertoire. As defined by the U.S. Food and Drug Administration (FDA), this...
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The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity
In the new era of healthcare digitalization, there is a golden opportunity in the overlap between digital health and Real-World Evidence (RWE). In...
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Global Postmarket Pharmacovigilance: A Generic Drug Perspective
Despite the recognized need for generic drug pharmacovigilance harmonization efforts, only a few studies compared generic drug postmarket safety and...
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Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey
BackgroundThe UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to...
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The multifaceted role of STAT3 pathway and its implication as a potential therapeutic target in oral cancer
Oral cancer is one of the leading causes of cancer-related deaths, and it has become a matter of serious concern due to the alarming rise in its...
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The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency
BackgroundDespite calls for the use of additional real-world evidence (RWE) during drug development, rates of inclusion at the regulatory stage...
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Application of QbD Elements in the Development and Manufacturing of a Lyophilized Product
Since the roll out of ICH Q8, Q9, and Q10 documents and FDA drafted a QbD CMC review MaPP (MAPP 5016.1), the regulatory agencies expect and encourage...
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A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study
BackgroundOncology drugs are frequently approved on the basis of surrogate outcomes that require further trials to confirm the benefits, but at times...
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Study on Horizon Scanning with a Focus on the Development of AI-Based Medical Products: Citation Network Analysis
Horizon scanning for innovative technologies that might be applied to medical products and requires new assessment approaches to prepare regulators,...
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A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States
PurposeScientific information in the drug labeling is expected to be the most up-to-date and consistent information across countries where medicine...
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New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19
The urgency and impact of the ongoing COVID-19 pandemic are changing global drug development and regulatory processes. The need for speed to...
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COVID-19 therapeutics: how to sow confusion and break public trust during international public health emergencies
Since SARS-CoV2 was declared a Public Health Emergency of International Concern , those tasked with the stewardship of public health at a global,...
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Solution Oligonucleotide APIs: Regulatory Considerations
Manufacture of oligonucleotide active pharmaceutical ingredients (APIs) typically consists of solid-phase synthesis, deprotection and cleavage,...
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Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response
Certain innovative technologies applied to medical product development require novel evaluation approaches and/or regulations. Horizon scanning for...
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Training on adequate use of opioid analgesics in West and Central Africa: a neglected step on the way to access to essential medicines?
Alleviating acute and chronic pain is a moral imperative for health professionals and health systems, and it requires adequate access to and use of...
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Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability
The complexity and inter-connectedness of operating in a global world for drug product supply has become an undeniable reality, further underscored...
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The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today
Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access,...