[vc_row][vc_column][vc_column_text] 1. Background After new investigational drug pre-clinical stage 1 was completed, and IND (Investigational New Drug application) or CAT (Clinical Trial Application) submission to the FDA or CE [...]
Background and history In 1938, the FFDCA (Federal Food, Drug and Cosmetic Act) granted FDA cosmetic products and ingredients regulation authorization. The statutory provisions of the FFDCA addressing cosmetics [...]
[vc_row][vc_column][vc_column_text] 1. Background Many Bio-Pharmaceutical and biological products are based on (different) cell-type fermentation. Bio-Pharmaceutical products can be either intra or extra cellular metabolites that have a pharmacological effect. [...]