Business Intelligence on Biologic and Small Molecule Drugs
Figure 2 USFDA’s tentative approval regulatory pathways for drugs used by PEPFAR
Infographic of USFDA's tentative approval regulatory pathways for drugs used by PEPFAR, as well as, legal restrictions, and timelines. The infographic depicts (from top to bottom) the overall process for receiving and reviewing an application for PEPFAR. The process is divided horizontally into four distinct processes: Process 1 – initial drug registration for the innovator product(s) that serve as the reference for drugs used by PEPFAR; Process 2 – the various regulatory pathways available for drugs used by PEPFAR; Process 3 – legal restrictions and considerations for tFDA application submission for PEPFAR programme; and Process 4 – determination of priority versus standard reviews and related review timelines. USFDA, US Food and Drug Administration; PEPFAR, President's Emergency Plan for AIDS Relief.
Infographic of USFDA's tentative approval regulatory pathways for drugs used by PEPFAR, as well as, legal restrictions, and timelines. The infographic depicts (from top to bottom) the overall process for receiving and reviewing an application for PEPFAR. The process is divided horizontally into four distinct processes: Process 1 – initial drug registration for the innovator product(s) that serve as the reference for drugs used by PEPFAR; Process 2 – the various regulatory pathways available for drugs used by PEPFAR; Process 3 – legal restrictions and considerations for tFDA application submission for PEPFAR programme; and Process 4 – determination of priority versus standard reviews and related review timelines. USFDA, US Food and Drug Administration; PEPFAR, President's Emergency Plan for AIDS Relief.