Application to Market New Drug, Biologic, or Antibiotic for Human Use

An application submitted to a regulatory agency according to the Title 21, Code of Federal Regulations, Parts 314 and 601 in order to seek permission to market a new pharmaceutical, or biological agent, or antibiotic for human use. (NCI Thesaurus)

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Application Site

The anatomic site at which medical intervention is administered.

Application Security Issue Medical Device Problem

Issue associated with the acquisition of computer programming codes that can replicate and spread from one computer system to another thereby leading…

Application Program Issue Associated with Medical Device

Issue associated with the requirement for software to fulfill its function within an intended use or application.

Application Program Interface

A set of protocols designed to provide communication between a software application and a computer operating system or between applications.

Application Network Issue Associated with Medical Device

Issue associated with the deviations from documented system specifications that affects overall system performance and/or the performance of an individual device or…

Application Form: FDA Form 356h

A form submitted with an original BLA/NDA and subsequent submissions to that BLA/NDA.