DRUG DISCOVERY DEVELOPMENT (DDD): Intended to TREAT SEVERELY DEBILITATING or life
THREATENING ILLNESSES

Regulations are made to EXPEDITE the DEVELOPMENT
and APPROVAL PROCESS

FDA are allowed to approve a new drug BASED ON
SURROGATE ENDPOINT (likely to predict therapeutic
response)

Question

Intended to TREAT SEVERELY DEBILITATING or life
THREATENING ILLNESSES

Regulations are made to EXPEDITE the DEVELOPMENT
and APPROVAL PROCESS

FDA are allowed to approve a new drug BASED ON
SURROGATE ENDPOINT (likely to predict therapeutic
response)

LEIGHTON DWIGHT OBILLOS · Accepted Answer

Rapid Access To New Drug Products

Intended to TREAT SEVERELY DEBILITATING or life THREATENING ILLNESSES Regulations are made to EXPEDITE the DEVELOPMENT and APPROVAL PROCESS FDA are allowed to approve a new drug BASED ON SURROGATE ENDPOINT (likely to predict therapeutic response)