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Regulatory Terms Starting With N
4 terms in the N index.
New Chemical Entity Exclusivity (NCE)
FDA's 5-year marketing exclusivity for the first approval of a drug containing a novel active moiety.
New Drug Application (NDA)
A formal request to the FDA for approval to market a new pharmaceutical drug in the United States.
Nitrosamine Impurity (Nitrosamine)
A class of genotoxic impurities that can form during drug substance or drug product manufacturing and require risk assessment and control.
No Observed Adverse Effect Level (NOAEL)
The highest dose in a toxicology study that does not produce a statistically or biologically significant adverse effect compared to controls.