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 […]
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 approval of Heritable Intentional Genomic Alterations (IGAs) in animals. IGAs involve deliberate genetic changes introduced into animals’ DNA to produce specific traits or health benefits that can be passed down to […]
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 in animal food. This guidance replaces the previous Memorandum of Understanding (MOU) between the FDA and the Association of American Feed Control Officials (AAFCO), which expired in 2022. The AFIC process […]
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | Shudarsana Company
The U.S. Food and Drug Administration (FDA) has issued detailed guidance under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to address the responsibilities of medical device manufacturers in reporting manufacturing changes that could lead to device shortages, particularly during a public health emergency (PHE). This guidance helps ensure the availability […]
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers
The U.S. Food and Drug Administration (FDA) recently released a guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” This guidance provides a framework for how pharmaceutical and medical device companies can communicate scientific information about unapproved uses of their products […]
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 […]
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act | Shudarsana Company
FDA Issues Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act In January 2025, the U.S. Food and Drug Administration (FDA) released updated guidance titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act” to clarify the circumstances under […]
FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: The FDA is investigating reports of T-cell malignancies, including CAR-positive lymphoma, in patients treated with BCMA- or CD19-directed autologous CAR T cell immunotherapies. These reports stem from both clinical trials and postmarketing data. All currently approved […]
FDA Expands Actions Against Problematic Plastic Syringes from China
FDA Expands Actions Against Problematic Plastic Syringes from China In a recent update, the U.S. Food and Drug Administration (FDA) has announced expanded measures to address concerns regarding the quality and performance of plastic syringes manufactured in China, with a particular focus on Jiangsu Shenli Medical Production Co. Ltd. The FDA’s latest actions include the […]