Background After a new investigational drug pre-clinical stage 1 is completed, and a US IND (Investigational New Drug application) or EU CTA (Clinical Trial Application) submission to the [...]
The purpose of medical device cleaning validation is to assure that the medical device cleaning procedure consistently controls potential carryover, contaminants, cleaning agents and extraneous material into the [...]
The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, medical devices and combination products. Risk management is a [...]
Background and history In 1938, the Federal Food, Drug and Cosmetic Act (FFDCA) granted FDA authorization for regulation of cosmetic products and ingredients. The statutory provisions of the [...]
