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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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Post-market safety data for underrepresented populations in clinical trials

Blogs, Pharmacovigilance /

Introduction Regulatory agencies require sponsors to collect and provide data on the safety and efficacy of drugs that they have obtained from clinical trials. In addition to age, gender, and racial subgroups, these trials should also incorporate data on patient populations that are historically underrepresented in clinical research. Indeed, information from a diverse patient population

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Guidance on Informed Consent in Clinical Investigations

Blogs, Medical Writing, Regulatory /

Within the realm of clinical research, the process of obtaining informed consent stands as a crucial cornerstone of ethical practice, serving to protect the rights and well-being of human participants. The U.S. Food and Drug Administration (FDA) recognizes the changing landscape of clinical investigations and the necessity to align with the 2018 Common Rule and

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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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Public Health Emergencies

Mitigating medical device shortages in public health emergencies

Blogs, Medical Device, Regulatory /

The onset of the pandemic amplified an already growing concern in the European Union (EU)- the shortage of medicines, equipment, and devices that subsequently burdens the health system and puts patients at risk. Some of the reasons for these kinds of shortages are related to problems in manufacturing that can delay production, shortages of raw

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Digitalization in Regulatory Affairs

Digitalization in Regulatory Affairs

Blogs, Regulatory /

Technology is rapidly driving the growth of the Pharmaceutical and Life Sciences industries. With digital solutions being made more easily available, drug development & pharmacovigilance are transforming to become more efficient, compliant, and patient safety focused. However, regulatory affairs is still somewhat manual where processes and tasks are repetitive, siloed, and resource-heavy. Though Life Sciences

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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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