A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

New Chemical Entity-NCE

The New Chemical Entity is a new Drug Substance / Active Pharmaceutical Ingredient (API), which has not been previously registered in a business region.

or

The designated therapeutic moiety (API) in a dosage form that has not been approved for marketing in the United States (also referred to as a new chemical entity or new drug substance). It may be a complex, simple ester, or salt of a previously approved API.

New Drug Application-NDA

The New Drug Application is the company’s registration file sent to the FDA for the marketing of a new drug product in the United States.

or

A formal application to the FDA for approval to market a new drug product. When the investigational phase of a drug is completed, the manufacturer gathers together the results of all studies and submits them to the FDA in a New Drug Application. This application is reviewed in detail by a team of reviewers. The purpose of the NDA is to determine whether the drug meets the statutory standards for safety, effectiveness, labeling and manufacturing.

Non-fiber-releasing filter

Any filter which, after any appropriate treatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.

Non-viable Particulate

A non-viable particulate is any type of particle, which is not living microorganisms.

Nonconformity

Nonfulfillment of a specified requirement.