Global Unique Device Identification Database (GUDID) | Shudarsana Company
The U.S. Food and Drug Administration (FDA) has outlined specific requirements for medical device manufacturers regarding adverse event reporting under the Medical Device Reporting…
Read more →Institutional Review Board (IRB) Written Procedures | Shudarsana Company
FDA Issues New Guidance on IRB Written Procedures: Key Insights for Institutions The U.S. Food and Drug Administration (FDA) has released updated guidance on…
Read more →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…
Read more →CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process | Shudarsana Company
Understanding the FDA’s Guidance on Heritable Intentional Genomic Alterations (IGAs) in Animals The FDA’s Guidance for Industry #187B provides a detailed roadmap for the…
Read more →CVM GFI #294 – Animal Food Ingredient Consultation (AFIC) | Shudarsana Company
The FDA’s Guidance for Industry #294 introduces the Animal Food Ingredient Consultation (AFIC) process, designed to improve the regulation and safety of ingredients used…
Read more →