Test
Exam 2 PPT Slides - New Drug Development & FDA Communications
Preguntas del test (5)
1Select the statements that pertain to Pre-IND (Investigational New Drug) that takes places in Phase 0.
- AReach agreement on animal studies required to initiate human studies
- BDiscuss scope & design for Phase 1 and pediatric studies
- CFormat of IND dossier
- DGenerally reserved for severely debilitating and life-threatening illness with accelerated approval program
2The 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- AVerdadero
- BFalso
3Orphan 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)
- AVerdadero
- BFalso
4Drug labeling includes:
- AA. All printed information accompanying a drug, label, wrapping & package insert
- BB. FDA Division of Marketing, Advertising & Communication seeks balanced, not misleading, scientifically accurate information for health care practitioners
- CC. Label claim (indication) is particularly important to sponsor because of its connection to reimbursement
- DD. A & B only
- EE. A and C only
- FAll the above
52016 Prescription Drug User Fee Agreement (PDUFA): ‘application fees for an application requiring clinical data ($________), for an application not requiring clinical data or a supplement requiring clinical data ($________)
- A$2,374,200 (requiring clinical data); $1,187,100 (not requiring clinical data)
- B$2,374,200(not requiring clinical data); $1,187,100(requiring clinical data)
Información
- Descripción
- Exam 2 PPT Slides - New Drug Development & FDA Communications
- Autor
- Kevin Vu
- Idioma
- English
- Visitas
- 94
- Etiquetas
- Valoración
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