Exam 2 PPT Slides - New Drug Development & FDA Communications

Question 1

Select the statements that pertain to Pre-IND (Investigational New Drug) that takes places in Phase 0.

Accepted Answer

Reach agreement on animal studies required to initiate human studies

Accepted Answer

Discuss scope & design for Phase 1 and pediatric studies

Accepted Answer

Format of IND dossier

Answer

Generally reserved for severely debilitating and life-threatening illness with accelerated approval program

Question 2

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

Question 3

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

Question 4

Drug labeling includes:

Accepted Answer

All the above

Answer

A. All printed information accompanying a drug, label, wrapping & package insert

Answer

B. FDA Division of Marketing, Advertising & Communication seeks balanced, not misleading, scientifically accurate information for health care practitioners

Answer

C. Label claim (indication) is particularly important to sponsor because of its connection to reimbursement

Answer

D. A & B only

Answer

E. A and C only

Question 5

2016 Prescription Drug User Fee Agreement (PDUFA): ‘application fees for an application requiring clinical data ($________), for an application not requiring clinical data or a supplement requiring clinical data ($________)

Accepted Answer

$2,374,200 (requiring clinical data); $1,187,100 (not requiring clinical data)

Answer

$2,374,200(not requiring clinical data); $1,187,100(requiring clinical data)

Exam 2 PPT Slides - New Drug Development & FDA Communications

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