Regulatory Terms Starting With N

4 terms in the N index.

• New Chemical Entity Exclusivity (NCE)

  New Chemical Entity Exclusivity is a five-year FDA marketing exclusivity awarded on the first approval of a drug whose active moiety has never been approved, blocking ANDA and 505(b)(2) submissions rather than merely their approval.

• New Drug Application (NDA)

  A New Drug Application (NDA) is the marketing application a sponsor submits to obtain FDA approval to market a new drug in the United States, carrying the complete safety, effectiveness, manufacturing, and labeling record supporting that decision.

• Nitrosamine Impurity (Nitrosamine)

  Nitrosamine impurities are N-nitroso compounds that form in or contaminate drug substances and drug products; ICH M7(R2) places them in the cohort of concern, so each needs a substance-specific acceptable intake, not the generic 1.5 microgram threshold.

• No Observed Adverse Effect Level (NOAEL)

  No Observed Adverse Effect Level is the highest dose in a nonclinical toxicology study producing no biologically significant adverse finding relative to controls, and it anchors the human starting dose for a first-in-human trial.