Exam (elaborations)
RAC Exam practice/128 Questions with Complete solutions
- Course
- Institution
RAC Exam practice/128 Questions with Complete solutions
[Show more]
Seller
Follow
Victorious23
Reviews received
Content preview
RAC Exam practice/128 Questions withComplete solutions
Which of the following was NOT a requirement of the original Food Drug and
Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized
standards of identify d) Safe tolerances for unavoidable poisonous
substances(1:1) - -A: Proof of efficacy
-Which amendments to the FD&C Act resulted from the thalidomide
tragedy? a) Durham-Humphrey Amendments b) Hatch-Waxman Act c)
Controlled Substances Act d) Kefauver-Harris Amendments (1:2) - -D:
Kefauver-Harris Amendments
-The Color Additive Amendment of 1960 required FDA to prove that a color
additive was unsafe before removing it from the market. a) True b)
False(1:3) - -B: False
-What has been described as "the most extensive change to the agency's
practices since 1938?" a) Prescription Drug User Fee Act of 1922b) GMPs for
the 21st Century initiative c) Food and Drug Administration Modernization
Act d) Food and Drug Administration Amendments Act(1:4) - -C: Food and
Drug Administration Modernization Act
-Both regulations and guidance documents have the force of law. True or
False?(2:1) - -False. Only regulations have the force of law.
-Although FDA's statutory authority does not extend to the occupational
safety and health responsibilities of OSHA the agencies coordinate their
efforts in matters of related responsibility such as unshielded syringes and
natural rubber latex. True or False?(2:2) - -True
-An FDA petition much contain which of the following? a) Action requested b)
Statement of grounds c) Environmental impact d) All of the above(2:3) - -D:
All of the above
-Drugs may be eligible for over-the-counter status when: a) They have been
marketed to a material extent b) They have been marketed for a material
time c) Are generally recognized as safe d) All of the above(2:4) - -D: All of
the above
-Biologics are cleared for marketing through which process ?a)
Establishment License Application (ELA)b) Product License Application
(PLA)c) Biologics License Application (BLA)d) All of the above(2:5) - -C:
Biologics License Application (BLA)
, -A Special 510(k) relies on the following information: a) Design control
documentation b) Guidance documents c) Consensus standards d) All of the
above(2:6) - -A: Design control documentation
-Which act required rulemaking meetings to be open to the public? a)
Moonshine Act b) Government in the Sunshine Act c) Food Drug and
Cosmetics Act d) Administrative Amendments Act(2:7) - -B: Government in
the Sunshine Act
-Which of the following does not distinguish the development of drugs for
animal use from those for human use: a) The ability to use known data from
the development of a drug for use in humans or other animal species as
applicable. b) Generally safety and efficacy studies require only 10s of
animals per group compared to the 100s of patients per group required for
human drugs. c) Does not have user fees for NADAs. d) Species class and
breed of animals as well as geographical differences are more relevant.(3:1)
- -C: Does not have user fees for NADAs.
-A generic drug is deemed bioequivalent to the RLD if in clinical
bioequivalence studies the 90% confidence intervals for the ratio of
population geometric means between the two treatments based on log-
transformed data is contained within the equivalence limits of ____% - ____%
for AUC and Cmax. a) 80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - -D: 80%
and 125%
-What is the definition of a biologic?(3:3) - -A substance derived from or
made with the aid of living organisms.
-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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Victorious23. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $12.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
75632 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now