In the early days of drug development, pioneers had two routes: the traditional New Drug Application (NDA) or its generic type, the Abbreviated New Drug Application (ANDA). The NDA involved extensive original comprehensive research and clinical trials, while the ANDA was a well-travelled path for a generic drug, relied on safety and efficacy data of […]
Navigating the 505(b)(2) Approval Pathway Read More »
In vitro diagnostic medical devices (IVD devices) are an integral part of the healthcare system. They are typically used to analyze samples that are collected from the human body (i.e., saliva, blood, tissue, and urine) and help in diagnosing, screening, and monitoring various conditions. IVD devices are subjected to different regulations that specify different requirements
Specifications for In Vitro Diagnostic Devices Read More »
Improving access to clinical trial information is critical in order to advance medical research while also ensuring patient safety. Enhanced transparency can not only accelerate innovation but also empower various stakeholders to make appropriate and informed decisions in order to progress medical research forward. The European Medicines Agency (EMA) has introduced several improvements in the
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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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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
Emerging Drug Safety Technology Program Read More »
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
Ensuring Transparency for Machine Learning-Enabled Medical Devices Read More »
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
Clinical Evaluation of Orphan Medical Devices 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 »
