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 […]
Guidance on Informed Consent in Clinical Investigations Read More »
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
Understanding the FDA’s Abbreviated New Animal Drug Application Pathway Read More »
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
Mitigating medical device shortages in public health emergencies Read More »
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
Digitalization in Regulatory Affairs Read More »
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
Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products Read More »
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
Technological Transformation in Pharmacovigilance Read More »
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
Nanobodies vs Antibodies in the Fight Against Covid Read More »
From pre-clinical phases to post-marketing follow-up studies, the drug development process is a challenging, expensive, and time-consuming process that can take many years to complete. Companies spend millions of dollars and countless hours to test the effectiveness of their new drugs. To save cost and time, pharmaceutical companies are incorporating ai in drug discovery process
Enhancing Drug Discovery Process Through Artificial Intelligence Read More »
The Russia-Ukraine war has undoubtedly affected millions of people in and around the world. Several industries have taken a huge hit where operational and business continuity has been threatened, the pharmaceutical industry being one of them. From the delays along the drug development pipeline, to non-compliance products in the market being at risk, the industry
The impact of the Russia-Ukraine war on clinical trials Read More »
The 7th of April 2022 marked the 74th anniversary of the founding of WHO in 1948 which is celebrated annually as ‘World Health Day’. Each year draws attention to a specific health topic of concern to people all over the world. The onset of the pandemic has created history and has affected billions of people
The First WHO Global Centre For Traditional Medicine in Gujurat, India Read More »
