DRUG DISCOVERY DEVELOPMENT (DDD): 1 GIVEN TO NEW DRUG PRODUCTS with
IMPROVED THERAPEUTIC EFFECTS, safety, side effects in COMPARISON to the MARKETED DRUG, reviewed in timely manner

2) 60 days- decision to accept NDA from the date of
submission

Question

1 GIVEN TO NEW DRUG PRODUCTS with
IMPROVED THERAPEUTIC EFFECTS, safety, side effects in COMPARISON to the MARKETED DRUG, reviewed in timely manner

2) 60 days- decision to accept NDA from the date of
submission

LEIGHTON DWIGHT OBILLOS · Accepted Answer

1 “P” Priority review

2 “S” Standard review

1 GIVEN TO NEW DRUG PRODUCTS with IMPROVED THERAPEUTIC EFFECTS, safety, side effects in COMPARISON to the MARKETED DRUG, reviewed in timely manner 2) 60 days- decision to accept NDA from the date of submission