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 […]
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