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Author name: development

The Use of EDDO to Ensure Drug Delivery Function

Blogs, Medical Device, Regulatory /

When it comes to ensuring the safety and effectiveness of medical devices intended to deliver drugs, understanding Essential Drug Delivery Outputs (EDDO) is important. The advent of drug-device combination products has necessitated the development of robust guidelines to ensure safety, efficacy, and performance. One such crucial aspect of these combination products is the Essential Drug […]

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Emerging Drug Safety Technology Program

Blogs, Pharmacovigilance /

Pharmacovigilance practices are associated with several challenges related to collection of safety data, processing, assessment, and volume of patient safety data. As technological disruptors- like artificial intelligence (AI)- develop, so do the solutions to tackle such challenges. This leads to more efficient pharmacovigilance (PV) systems and processes that ultimately enhance drug safety monitoring. Whether it

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Machine Learning-Enabled Medical Devices

Ensuring Transparency for Machine Learning-Enabled Medical Devices

Blogs, Medical Device /

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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Clinical Evaluation of Orphan Medical Devices

Blogs, Clinical Regulatory, Medical Device, Regulatory /

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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Safety Testing of Allogeneic Cells used in Cell Based Medical Products

Insights, Medical Writing, Pharmacovigilance, Regulatory /

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

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Recommendations for the use of Animal & Human Derived Materials in Cell and Gene Therapy Products

Blogs, Clinical Regulatory, Regulatory /

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

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Accelerating Product Registration with SFDA’s Priority Review

Blogs, Regulatory /

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

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REMS Logic Model: Framework to link program design with assessment

Blogs, Pharmacovigilance, Regulatory /

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

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