This application is required
before a new drug can be approved for commercial use. The NDA must
contain: full reports of clinical investigations demonstrating that the
drug is safe and effective, a list of components, a statement of the
drug's quantitative composition, a description of the methods used for
the manufacturing, processing and packaging of the drug, samples and the
proposed label.
Would you like information like this delivered to your email inbox? Subscribe to Tradeline Updates to keep abreast of the latest conference developments, industry news, best practices and more!
Printer Friendly Version
Send to a Friend
