FIGURE 2-1 Four stages of the drug system.

NOTE: AADA = Abbreviated Antibiotic Drug Application; ANDA = Abbreviated New Drug Application; BLA = Biologic Licensing Application; DTC = direct to consumer; FDA = U.S. Food and Drug Administration; IND = Investigational New Drug Application; NDA = New Drug Application; OTC = over-the-counter; PBM = Pharmacy Benefits Manager.

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement