Select the statements that pertain to Pre-IND (Investigational New Drug) that takes places in Phase 0.
Reach agreement on animal studies required to initiate human studies
Discuss scope & design for Phase 1 and pediatric studies
Format of IND dossier
Generally reserved for severely debilitating and life-threatening illness with accelerated approval program
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
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)
Drug labeling includes:
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
D. A & B only
E. A and C only
All the above
2016 Prescription Drug User Fee Agreement (PDUFA): ‘application fees for an application requiring clinical data ($________), for an application not requiring clinical data or a supplement requiring clinical data ($________)
$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)
