By Dr. Bill F. Hodnick, DABT If you are developing a radiopharmaceutical drug and preparing for an Investigational New Drug (IND) filing, understanding nonclinical requirements set by the Food and Drug Administration (FDA) is e...
FDA issued Revision 2 of the guidance for industry Control of Nitrosamine Impurities in Human Drugs. As a class of compounds, nitrosamines are potent genotoxins both in vitro and in several animal species. Some nitrosamines a...
In the fast-paced world of life sciences product development, regulatory submissions are not just a procedural requirement, they are a cornerstone of asset development and a requirement to getting novel and innovative products ...
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