At DDReg, we believe in nurturing a strong company culture that celebrates our shared values and national pride. We had the privilege of commemorating the 77th Indian Independence Day at our headquarters, where the team came together for a day filled with joy, unity, and patriotism. Independence Day Celebrations- Patriotism, Team Building and Festive Fun […]
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Transparency in Machine Learning-Enabled Medical Devices (MLMDs) refers to the degree to which relevant information about a device—such as its intended use, the development process, performance, and logic—is clearly communicated to stakeholders. Why is this important? To help the development of safe, effective, and high-quality AI/ML learning technologies. These may learn from real-world data and
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In the European Union, the Medical Device Coordination Group (MDCG) continues to address unique challenges in the medical field, by bringing life-changing orphan medical devices to patients who suffer from rare conditions. These devices that are intended for a small number of individuals are subject to various hurdles in their development and market introduction. The
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Cell based medicinal products use a single source of cells to treat multiple patients. For example, allogeneic cell therapies use donor cells to create a Master Cell Bank (MCB) that are then processed to be used in different kinds of therapies. The use of allogeneic cells to develop medicinal products and therapies demands rigorous testing
Safety Testing of Allogeneic Cells used in Cell Based Medical Products Read More »
The number of cell and gene therapies coming into the market each year is increasing steadily. An article published by McKinsey and Company in 2022 expected as many as 21 cell therapy and 31 gene therapy launches in 2024 itself. The growing focus on cell and gene therapies (CGT) presents a unique set of challenges to
It is important for regulatory agencies to implement priority review processes in order to expedite drug approval processes. This ensures fast access to safe innovative treatments and life-saving medicines. By streamlining drug review processes that address unmet medical needs, or offer better treatment options compared to existing therapies, these processes can accelerate patient access. This
Accelerating Product Registration with SFDA’s Priority Review Read More »
Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in ensuring that the benefits of a drug outweigh its risks. These strategies are particularly important for medications with significant safety concerns and require a well-structured approach to both design and assessment. The FDA’s guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model presents
REMS Logic Model: Framework to link program design with assessment Read More »
The Indian healthcare system has been traditionally plagued by challenges such as inadequate infrastructure, limited access to quality care, and a shortage of skilled professionals, is witnessing a paradigm shift with the advent of Generative Artificial Intelligence (GenAI). GenAI is an AI subset dedicated to the creation of new content by learning patterns from existing
Impact of GenAI on Indian Healthcare Read More »
clinical trial simulation Artificial Intelligence (AI) entails the use of computer techniques that make it possible for machines to undertake activities such as perception, reasoning, learning, and decision-making. New AI forms are being developed owing to progress in technology which has fueled developments in sectors such as facial recognition, finance strategy, autonomous cars etc. The
Machine Learning and Simulations for Clinical Trials Read More »
The world of regulatory submissions is transforming where static documents and data tables are slowly giving way to a more dynamic approach – interactive safety graphics. Traditional methods of presenting this data have evolved significantly with the advent of interactive safety graphics. These dynamic tools are transforming the way submission content is reviewed, how clinical study reports
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