4044735
Question 1
Question
Select the statements that pertain to Pre-IND (Investigational New Drug) that takes places in Phase 0.
Answer
-
Reach agreement on animal studies required to initiate human studies
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Discuss scope & design for Phase 1 and pediatric studies
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Format of IND dossier
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Generally reserved for severely debilitating and life-threatening illness with accelerated approval program
Question 2
Question
The FDA has three types of meeting:
- Type A meeting: to help an otherwise stalled development program
- Type B meeting: pre-IND, end-of Phase 1, end-of Phase 2, pre-Phase 3, pre-Biologics License Application (BLA)
- Type C: occurs within 75 days of FDA receipt of request
Answer
- True
- False
Question 3
Question
Orphan drug: to treat rare medical conditions (orphan disease), affecting fewer than 300,000 patients in USA, may be sold without competition for seven years, National Organization of Rare Diseases (NORD) & European Organization for Rare Diseases (EURORDIS)
Answer
- True
- False
Question 4
Question
Drug labeling includes:
Answer
-
A. All printed information accompanying a drug, label, wrapping & package insert
-
B. FDA Division of Marketing, Advertising & Communication seeks balanced, not misleading, scientifically accurate information for health care practitioners
-
C. Label claim (indication) is particularly important to sponsor because of its connection to reimbursement
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D. A & B only
-
E. A and C only
-
All the above
Question 5
Question
2016 Prescription Drug User Fee Agreement (PDUFA): ‘application fees for an application requiring clinical data ($________), for an application not requiring clinical data or a supplement requiring clinical data ($________)
Answer
-
$2,374,200 (requiring clinical data); $1,187,100 (not requiring clinical data)
-
$2,374,200(not requiring clinical data); $1,187,100(requiring clinical data)
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