In the past four decades, the number of drugs being approved by the FDA has increased significantly. Interestingly, while the number of products has only increased, the time taken by the FDA to review and eventually market them has steadily decreased. A recent article by Seoane-Vazquez and team shows that while the median time to […]
Expediting Access to Cell and Gene Therapy Products Read More »
The medical device industry is driven by constant technological advancements and the need to meet growing patient demands. Ensuring that these innovations are safe, effective, and reach the market promptly is a critical aspect of public health. To address this need, the FDA has implemented the Total Product Life Cycle (TPLC) Advisory Program (TAP), a
Enhancing Medical Device Innovation with the Total Product Life Cycle Advisory Program Read More »
Gene therapy is recognized as a revolutionary approach in treating and potentially curing genetic disorders by correcting or replacing faulty genes. As the field progresses, navigating through the regulatory landscape for gene therapy trials in the European Union (EU) can be intricate due to a combination of clinical trial regulations and environmental legislation. Despite the
Exploring the Evolving Regulatory Landscape for Gene Therapy Trials in the EU Read More »
In the pursuit of global harmonization in pharmaceutical regulation, Japan which is renowned for its meticulous standards and innovative spirit, has taken a significant step by implementing the Electronic Common Technical Document (eCTD) v4.0. This move aligns Japan with international standards set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human
Japan’s Approach to eCTD V4.0 Read More »
The accelerated approval pathway is established to expedite the availability of drugs for serious or life-threatening conditions. It allows the FDA to approve treatments based on surrogate or intermediate endpoints before confirmatory studies are completed. This pathway has been instrumental in advancing treatments for rare diseases and unmet medical needs, relying on a balance between
Does the FDA need a new approval pathway? Read More »
The convergence of healthcare with technology has led to giant innovations, one of the most significant being the use of software and artificial intelligence (AI) as medical devices. Such developments have been called Software as a Medical Device (SaMD) by many and have wide applicability in transforming the diagnosis, treatment, and care of patients medically.
Regulatory Framework for Software and Artificial Intelligence as Medical Device Read More »
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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