At the turn of the millennium, guidelines for post-marketing safety reporting of herbal medicines were introduced by the World Health Organization (WHO) in the period between 1999 and 2001. The fact that more than 158 million people in the United States alone spent over 17.6 billion dollars on herbal medicines in the year 2000 is […]
Pharmacovigilance in Herbal and Alternative Medicine Read More »
The safe and effective use of medical devices in healthcare facilities is not merely a matter of convenience; it is a moral obligation. The welfare of patients and the quality of healthcare services depend on the responsible use of these devices. Accidents involving medical devices can have dire consequences for patients. These accidents may result
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The Center for Drug Evaluation and Research (CDER) of the US FDA outlined a program in February 2019 in which various stakeholders of the industry could propose pharmaceutical quality standards for recognition by the CDER. This would provide the industry with additional resources for the development and manufacturing of pharmaceuticals. In July 2023, the CDER
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The rapid digitalization of the biomedical and clinical research sectors has ushered in a new era of advancements, with artificial intelligence (AI) taking centre stage as a transformative solution. In particular, AI is revolutionizing drug discovery processes by harnessing the vast amount of data generated during molecule screening phases and preclinical studies. As a result,
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The Certificate of Suitability (CEP) to the monographs of the European Pharmacopoeia (Ph. Eur.) plays a crucial role in verifying the quality standards of active pharmaceutical ingredients (APIs). Issued by the European Directorate for the Quality of Medicines (EDQM), the CEP serves as evidence that an API complies with the rigorous quality requirements outlined in
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Over-The-Counter (OTC) monographs define the safety, effectiveness, and labelling of the active ingredients in OTCs. The US FDA released a guidance document that provides suggestions for industry and review staff on resolving scientific and medical disputes related to OTC monograph drugs. It describes the Center for Drug Evaluation and Research (CDER) formal dispute resolution (FDR)
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In this new era, where different therapeutic realms converge, the emergence of combination products has revolutionized the healthcare landscape by providing more innovative treatment options to treat the unmet medical needs of patients. However, with great power comes great responsibility. Continuously monitoring these products and ensuring they are safe to use is paramount in order
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Complex drugs add more value to patients compared to simple generics as they are capable of addressing unmet needs of patients for particular conditions. However, biopharmaceutical companies encounter distinctive hurdles when it comes to the advancement of complex generic drugs. These medications, known for their intricate characteristics or the requirement of additional clinical trials, necessitate
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Decentralized clinical trials (DCTs) are evolving and gaining momentum within medical research as they increasingly incorporate state-of-the-art digital health technologies (DHTs). Indeed by way of DHTs, useful data for clinical trials can be collected, exchanged, transferred, and stored electronically and in a more efficient manner. In order to stay aligned with the momentum, regulatory agencies
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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline update- the ICH E6 (R3)- that focuses on the application of Good Clinical Practice (GCP) to new trial designs, technological advancements, and enhancing a risk-based approach in clinical trials.The ICH E6 (R3) serves as an update to
Enhancing Good Clinical Practice for the Evolving Clinical Trial Landscape Read More »
