Control of Nitrosamine Impurities in Human Drugs
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring that the pharmaceutical supply chain remains resilient and that drug shortages are minimized. The FDA’s guidance document, “Manufacturing, Supply Chain, and Drug Shortages,” provides essential recommendations for drug manufacturers to maintain product availability and manage disruptions effectively. This article highlights key takeaways […]
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring that new drugs and biological products meet safety, efficacy, and quality standards before they reach the market. The FDA’s guidance document, “Benefit-Risk Assessment for New Drug and Biologic Approvals,” provides a structured framework for evaluating the benefits and risks associated with these […]
Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
In August 2024, the U.S. Food and Drug Administration (FDA) released the final guidance document titled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.” This guidance aims to assist sponsors in identifying optimized dosages for oncology drugs and biological products during clinical development, prior to submitting approval […]
M12 Drug Interaction Studies
In August 2024, the U.S. Food and Drug Administration (FDA) released the M12 Drug Interaction Studies Guidance for Industry, developed in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guidance aims to harmonize approaches in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical […]
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
In August 2024, the U.S. Food and Drug Administration (FDA) released the “FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products.” This technical specifications document provides detailed instructions for the electronic submission of Individual Case Safety Reports (ICSRs) in the E2B(R3) format to the FDA’s Adverse […]
CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
The U.S. Food and Drug Administration (FDA) has released the updated Guidance for Industry #100, titled “Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances, and Excipients (Revision 2), VICH GL18(R2).” This revision provides comprehensive recommendations for controlling residual solvents in veterinary medicinal products, ensuring animal safety and product quality. Understanding Residual Solvents in […]
Providing Over-the-Counter Monograph Submissions in Electronic Format
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. One of its key responsibilities is addressing cybersecurity risks, which have become increasingly significant as medical devices integrate more digital and network-based technologies. The FDA’s guidance document, “Cybersecurity in Medical Devices: Quality System Considerations and […]
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
The U.S. Food and Drug Administration (FDA) plays a critical role in regulating medical devices to ensure their safety and effectiveness. One area of growing importance is the remanufacturing of medical devices. The FDA’s guidance document, “Remanufacturing of Medical Devices,” provides essential recommendations for distinguishing between servicing and remanufacturing activities to maintain device integrity and […]
Container Closure System and Component Changes: Glass Vials and Stoppers
The U.S. Food and Drug Administration (FDA) has released guidance on Clinical Decision Support (CDS) software, which aims to clarify regulatory oversight and ensure the safety and effectiveness of such tools in healthcare. The guidance document, titled “Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff,” outlines the criteria for determining […]
