Business Intelligence on Biologic and Small Molecule Drugs
Figure 3 simplified administrative process of drug review and dissemination of information related to drugs for the PEPFAR programme
The simplified administrative process of drug review and dissemination of information related to drugs for the PEPFAR programme. The diagram flows from left to right, representing key distinct functions across two offices at the USFDA; and from top to bottom, displaying the various processes involved in fulfilling each function. USFDA, US Food and Drug Administration; PEPFAR, President's Emergency Plan for AIDS Relief; NDA, New Drug Application; ANDA, Abbreviated New Drug Application; TA, Tentative Approval; OIP, Office of International Programs; WHO, World Health Organization; PQP, Prequalification of Medicines Programme; USAID, US Agency for International Development.