Kevin Vu
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Exam 2 PPT Slides - New Drug Development & FDA Communications

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Exam 2 PPT Slides - New Drug Development & FDA Communications

Exam 2 PPT Slides - New Drug Development & FDA Communications

Question 1 of 5

1

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

Select one or more of the following:

  • 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

Explanation

Question 2 of 5

1

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

Select one of the following:

  • True
  • False

Explanation

Question 3 of 5

1

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)

Select one of the following:

  • True
  • False

Explanation

Question 4 of 5

1

Drug labeling includes:

Select one of the following:

  • 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

Explanation

Question 5 of 5

1

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

Select one of the following:

  • $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)

Explanation

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