Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | Shudarsana Company
Introduction In January 2025, the U.S. Food and Drug Administration (FDA) released crucial guidance titled “Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” This guidance addresses significant health risks linked to HCT/Ps, including outbreaks of Mycobacterium tuberculosis (Mtb) infections caused […]
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children | Shudarsana Company
FDA Guidance on Lead in Processed Baby and Toddler Food: Key Highlights and Impact The U.S. Food and Drug Administration (FDA) has issued a comprehensive Guidance for Industry to establish action levels for lead in processed food intended for babies and young children. This guidance is part of the FDA’s Closer to Zero initiative, which […]
Short Note on Regulation (EU) No 536/2014 on Clinical Trials
Regulation (EU) No 536/2014, enacted by the European Parliament and the Council on April 16, 2014, provides a comprehensive framework for the conduct of clinical trials on medicinal products for human use within the EU. It aims to ensure the protection of participants’ rights, safety, and well-being while facilitating the efficient and ethical conduct of […]
The EU Decentralised Clinical Trials Project: Revolutionizing Clinical Research
Background The landscape of clinical trials in the European Union (EU) is evolving, driven by the need for innovative trial designs and methodologies that address both emerging opportunities and inherent challenges. The EU Decentralised Clinical Trials (DCT) project is a pioneering initiative aimed at transforming the traditional clinical trial framework to enhance accessibility and convenience […]
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) What are ATMPs? Advanced therapy medicinal products (ATMPs) are a new and innovative type of medicine that uses genes, tissues, or cells to treat or prevent diseases. They work by repairing, replacing, or supplementing damaged or diseased cells and tissues. ATMPs can be used to treat a wide range of […]
Adaptive Pathways for Medicine Development
Adaptive pathways is an approach to medicine development that is based on iterative development, confirming benefit-risk balance, and gathering real world data. It applies to treatments in areas of high medical need. The European Medicines Agency (EMA) defines adaptive pathways as a flexible approach to clinical trial design, data analysis, and regulatory review that allows […]
Chapter 3: XEVPRM technical specifications, user guidance and practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
Chapter 3: XEVPRM technical specifications, user guidance and practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA: Chapter 3 of this comprehensive guide ventures into the heart of the electronic submission process for medicinal product information to the European Medicines Agency (EMA). This […]
Chapter 2: Electronic submission of information on medicinal products by MAH of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
Chapter 2: Electronic submission of information on medicinal products by MAH of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA : Chapter 2 of this detailed guide dives into the various avenues available for marketing authorization holders (MAHs) to electronically submit information on their medicinal products for […]
Chapter 1: Introduction of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
Chapter 1: Introduction of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA : This chapter serves as the introduction to the comprehensive guide on electronically submitting information on medicinal products for human use to the European Medicines Agency (EMA) by marketing authorization holders (MAHs). With […]