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Redesigned Pre-Submission Meetings for ANDAs with the US FDA

Insights, Regulatory /

Pre ANDA meetings facilitate pre-submission communications with the US FDA to discuss questions related to complex products and/or complicated drug development questions. These were introduced in GDUFA II. In the GDUFA III some pre submission meetings have been redesigned to support prospective applicants in obtaining feedback from the Agency regarding their complex generics or complicated […]

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Importance of Collaboration between Global Regulators

Insights, Regulatory /

Regulatory authorities across the globe play a pivotal role in safeguarding patient safety and ensure regulatory compliance. Each authority functions in its unique way to uphold standards and ultimately ensure the well-being of individuals. In the UK, the MHRA shoulders the vital responsibility of ensuring that medicines, medical devices, blood components for transfusion are safe, of

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The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products

Insights, Regulatory /

The field of gene therapy has witnessed significant advancements with the development of genome editing technologies. These technologies allow scientists to break, modify, and edit specific genes in a DNA sequence-specific manner, opening up new possibilities for gene therapy. While traditional gene therapy involves the addition of new genes to human cells or tissue, genome

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Navigating Drug Manufacturing Inspections

Insights, Regulatory /

The US FDA conducts drug manufacturing inspections for facilities to ensure they are compliant with the Current Good Manufacturing Practice (cGMP) standards. However, navigating through these inspections requires a clear and comprehensive understanding of several aspects. These include applicable manufacturing standards, site selection model, 483 forms, and how the FDA reviews the inspections and outcomes.

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How does EMA use Artificial Intelligence and Large Language Models in Medicine Regulation?

Insights, Regulatory /

Artificial Intelligence in Medicine Regulation– a perspective by Emer Cooke, Executive Director of the European Medicines Agency. Introduction Artificial Intelligence (AI) is revolutionizing the regulation of medicines by offering innovative solutions to enhance drug safety, efficacy, and overall patient well-being. With its ability to process vast amounts of data, identify patterns, and predict potential risks,

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Drug Application Pathway

Understanding the FDA’s Abbreviated New Animal Drug Application Pathway

Insights, Regulatory /

The level of scrutiny surrounding animal medicinal products has strengthened more adverse events (AEs) associated with such products have emerged in animals. Indeed, AEs and adverse drug reactions (ADRs) is a cause of concern for veterinarians. Several cases of toxicity from commonly used drugs have been reported, in canines, for example. These include licosamides that

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regulatory framework for cell, tissue, and gene therapy products

Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products

Insights, Regulatory /

Cell, tissue, or gene therapy products (CTGTPs) can contain non-viable or viable human cells or tissues, viable animal cells or tissues, or recombinant nucleic acids and are intended for use in humans to treat, prevent, or even diagnosis conditions that are associated with high treatment burden [1]. However, regulations surrounding CTGTPs vary per region as

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Transformation in Pharmacovigilance

Technological Transformation in Pharmacovigilance

Insights, Pharmacovigilance /

Technological disruption is rapidly occurring across all industries. In the pharmaceutical industry, technological contenders are gradually transforming the landscape of drug development, clinical trials, and pre-clinical phases. Indeed, this holds true for Transformation Pharmacovigilance and drug safety monitoring. Though the area of the industry is niche and highly regulated, hence the apprehension in incorporating technology

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Nanobodies vs Antibodies

Nanobodies vs Antibodies in the Fight Against Covid

Insights, Medical Writing /

Nanobodies are engineered small proteins that recognize and specifically bind to an antigen to initiate an appropriate signal- like antibodies. However, nanobodies bind to antigens with greater specificity and display other advantages over conventional antibodies. Extracted from camelids, these antibodies were found to comprise only of heavy chains, while demonstrating the same functions as conventional

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