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.
It is expected that the prototypes will be stored by Offeror until such time as (a) they can be used for pre-clinical or clinical development purposes under an Investigational New Drug application (IND), or (b) upon the FDA’s grant of an EUA under Section 564 of the Food, Drug and Cosmetic Act (FD&C Act), or full marketing approval under a full Biologics License Application (BLA) under Section 351(a) of the Public Health Service Act (PHSA).
Dermatological products marketed without FDA-approval via a New Drug Application, Abbreviated New Drug Application, or Biologics License Application MEDICAL BENEFITS BOOKLETThe Medical Benefits Booklet contains information not found in the prescription drug SPD.
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)].