Imagine a pharmaceutical company about to launch a new drug. Clinical trials have shown promising results, but the real test lies in how this drug will perform in the hands of thousands—or even millions—of patients in the real world. Will it be as effective? Will unexpected safety issues arise? The answers to these questions often […]
Designing Effective Pharmaco-Epidemiological Studies with ICH’s M14 Read More »
Diwali is a very special time in India, where everyone is in the spirit of celebrating goodness over evil and light over darkness. Family and friends come together and carry out their festive rituals and bring out all the lights and sparkles to commemorate the victory of good over evil. The best part about a
DDReg Diwali Gala 2024 Read More »
After a biosimilar or interchangeable product gets regulatory approval by the USFDA, manufacturers often need to adjust their manufacturing processes. These changes after approval are essential for keeping product consistency, enhancing processes, or tackling operational issues. However, because biologics are complex, even small modifications can significantly affect the product’s safety, efficacy, and quality. As a
The Declaration of Helsinki (DoH), the first international set of ethical guidelines for medical research involving human participants, marked its 60th anniversary this year. The members of the World Medical Association (WMA) General Assembly gathered to and unanimously approved significant revisions to the DoH. The DoH has always established that medical research involving human participants
Updates to the Declaration of Helsinki Read More »
The European Union (EU) has introduced stringent classification standards for Artificial Intelligence (AI) applications in medical devices and in vitro diagnostics (IVDs) to ensure patient safety, product efficacy, and compliance with regulatory frameworks. With AI technologies, these standards are crucial in defining the pathway for their integration into healthcare systems. This blog dives into the
Navigating EU Classification Standards for AI in Medical Devices and Diagnostics Read More »
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 »
At the DIA 2024 Global Annual Meeting in San Diego, key officials from the European Medicines Agency (EMA) shed light on the various expedited approval pathways available for sponsors of innovative drugs and Advanced Therapy Medicinal Products (ATMPs). This blog post explores the insights shared by EMA officials, delves into the various expedited pathways available,
How EMA’s Expedited Pathways and Scientific Advice Are Shaping Drug Approvals Read More »
DDReg is incredibly proud to announce that our Founder and Managing Director, Ms. Neeti Pant, has been chosen as a finalist by the prestigious CPhI panel for the “Woman of the Year” award at the CPhI Pharma Awards 2024, being held in Milan. This recognition is a testament to her visionary leadership, dedication to innovation,
Managing Director of DDReg chosen as finalist for CPhI Pharma Awards 2024 Read More »
