The biopharmaceutical industry is constantly evolving, and with it, regulatory standards are adapting to ensure the highest safety and efficacy for new biologics and drug products. A critical component of this regulatory landscape is the Bioresearch Monitoring (BIMO) inspections conducted by
The Accelerating Clinical Trials in the EU (ACT EU) initiative has taken a significant step forward with the launch of two new advice pilots aimed at enhancing the quality of clinical trial applications. These pilots are pivotal for advancing the development
The life sciences landscape is a bustling hub, constantly buzzing with innovation and adaptation. But staying ahead of the curve also means navigating a complex web of regulations. To help you chart your course, let's dive into some crucial updates impacting
In the ever-evolving field of healthcare, bringing a new medicine to market is a complex and highly regulated process. For pharmaceutical companies and individuals alike, understanding the intricacies of obtaining a license to market a medicine in the United Kingdom is
In December 2023, the U.S. Department of Health and Human Services, in collaboration with the Food and Drug Administration (FDA), released a groundbreaking guidance document titled "Data Standards for Drug and Biological Product Submissions Containing Real-World Data." This guidance is a
In the realm of life sciences, artificial intelligence (AI) has long been a cornerstone, driving advancements in drug discovery, clinical trial optimization, and personalized patient care. However, a new player has entered the scene, ushering in a wave of innovation that
In the ever-evolving landscape of global healthcare, a promising update has emerged, marking a significant step forward in the journey toward faster access to life-saving medications. The Therapeutic Goods Administration (TGA) in Australia has recently shared exciting news about the progress
Comprehensive Guidelines for the Development of Drugs and Biological Products to Combat COVID-19: Industry Insights The FDA's recommendations concentrate on phases 2 and 3 trials, encompassing critical elements such as trial population, design, efficacy endpoints, safety considerations, and statistical aspects. In
FDA Takes Steps to Improve Efficiency of PMR/PMC Submissions The Food and Drug Administration (FDA) has released draft guidance for industry on the use of new Forms FDA 3988 and FDA 3989 to submit information on post-marketing requirements (PMRs) and post-marketing
Predetermined Change Control Plans (PCCPs) for Machine Learning Medical Devices (MLMDs) Guiding Principles Artificial intelligence (AI) and machine learning (ML) are rapidly transforming healthcare. MLMDs are medical devices that use AI and ML to enhance their performance and capabilities. However, the
Navigating the Shifting Tides of Regulatory Compliance in Life Sciences In the dynamic world of life sciences, pharmaceuticals, and medical devices, staying updated on regulatory trends is essential for success. Let's explore the evolving landscape and how end-to-end regulatory services are
Implementing Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers in Singapore In its unwavering commitment to ensuring the highest standards of quality for therapeutic products available in Singapore, the Health Sciences Authority (HSA) is embarking on a significant regulatory
Navigating the FDA's New ANDA Filing Review Policies: What You Need to Know The US Food and Drug Administration (FDA) has recently implemented significant updates to its policies regarding the review process for Abbreviated New Drug Applications (ANDAs). This move marks
FDA's Electronic Submission Template for Medical Device 510(k) Submissions The Food and Drug Administration (FDA) is taking a significant step forward in streamlining the process for submitting premarket notification (510(k)) submissions for medical devices. This guidance document is designed to introduce
Navigating Regulatory Change in the Life Sciences Industry: Key Changes and Your Roadmap to Readiness In the rapidly evolving life sciences landscape, organizations are finding resilience to be a cornerstone of success, especially in the face of challenges like economic pressures,
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