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...
Nonclinical
Strong Regulatory Leadership Guidance in Streamlining Product Development
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 ...
gET sOCIAL