RAC Exam practice 2024 | Questions
with 100% Correct Answers | Verified |
Latest Update | Graded A+
What are the major categories of ICH guidelines?(3:4) - ✔✔Quality Safety
Efficacy Multidisciplinary
What is the deadline for an initial IND Safety report of a fatal or life-threatening
serious adverse event?(3:5) - ✔✔7 days
FDA promulgates regulations in which of the following? a) Code of
Federal Regulations b) Docket Management System c) Federal Register d)
Federal
Docket(4:1) - ✔✔C: Federal Register
What five types of application meetings are available to sponsors submitting
medical devices to CDRH?(4:2) - ✔✔Agreement Determination Pre-IDE Pre-
PMA and PMA day-100
,Under what circumstances is it appropriate to request a Type A meeting?(4:3) -
✔✔The Type A meeting is one that is immediately necessary for an otherwise
stalled drug development program to proceed. Type A meetings are reserved for
dispute resolution discussion of clinical holds and special protocol assessment
meetings.
True or False: A hearing to review the safety and efficacy of an NDC is a public
hearing before the commissioner. (4:4) - ✔✔False. A hearing to review the safety
and efficacy of an NDA is a public hearing before a public advisory committee.
True or False: FDA advisory committee meetings may be completely closed to the
public and notice of a meeting is not required to be published until the day of the
meeting. (5:1) - ✔✔False: Advisory committee meetings may be closed but
no advisory committee meeting can be completely closed (21 CFR 14.27)
,True or False: FDA advisory committees provide independent expert advice and
credibility to product reviews. (5:2) - ✔✔True
Where can you find guidance on the time frames for preparing briefing materials
for an advisory committee meeting?(5:3) - ✔✔"Guidance for Industry Advisory
Committee Meetings - Preparation and Public Availability of Information Given to
Advisory Committee Members (August 2008)"
True or False: There are 31 advisory committees within FDA.(5:4) - ✔✔True
Industry representatives are/are not voting members of an advisory committee
because they are independent of the sponsor company and represent the
industry as a whole.(5:5) - ✔✔Industry members are non-voting members of
an advisory committee. (21 CFR 14.84)
Stability testing of clinical trial materials and commercial drug products is
subject to: a) Good Laboratory Practice Regulations b) Good Scientific Practice
, Regulations c) Good Manufacturing Practice Regulations d) Both a and b e) None
f) All of the above(6:1) - ✔✔C: Good Manufacturing Practice Regulations
True or False: Good Laboratory Practice Regulations require the Quality Assurance
Unit to prepare a GLP Compliance Statement for inclusion in the final study
report(6:2). - ✔✔True
True or False: The Quality Assurance Unit must review and approve all standard
operating procedures applicable to a nonclinical test laboratory.(6:3) - ✔✔False
Test systems for nonclinical laboratory studies may include: a) Rodents b) Primates
c) Humans d) Canines e) Bacteria f) All of the above g) a b and c h) a b d
and e(6:4) - ✔✔H: a-Rodents b-Primates d-Canines and e-Bacteria
Corrections to the signed and dated final study report may be made in the form
of a report amendment by the: a) Quality Assurance Unit b) Test Facility
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