Examples of Biologics License Application in a sentence
Wound care products, including oral rinses, marketed without FDA-approval via a New Drug Application, Abbreviated New Drug Application, or Biologics License Application.
Dermatological products marketed without FDA-approval via a New Drug Application, Abbreviated New Drug Application, or Biologics License Application.
The Vendor acknowledges that each Product has, if required by law, an FDA- certified New Drug Application, an Abbreviated New Drug Application, or a Biologics License Application on file and accepts the liability with which such application confers.
The anticipated regulatory strategy (e.g., additional nonclinical or clinical studies anticipated/required, FDA or regulatory authority meetings desired, industry partnerships) for movement of the research into later phases of development and to support a potential marketing application [e.g., New Drug Application, Biologics License Application, Premarket Approval Application, 510(k)].
Womack commanded launch crews inside of silos in both Arkansas and California during the first ten years of the Titan II program.