RAC Practice Exam 1 Questions and Answers Latest Update (Complete Test Bank 100% Correct)
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Course
RAC
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RAC
RAC Practice Exam 1 Questions and Answers Latest Update (Complete Test Bank 100% Correct)
Which of the following does NOT describe requirements for reserve samples?
A A reserve sample representative of one lot of shipped product per year must be retained.
B The reserve sample should be at le...
RAC Practice Exam 1 Questions and
Answers Latest 2024-2025 Update
(Complete Test Bank 100% Correct)
Which of the following does NOT describe requirements for reserve samples?
A A reserve sample representative of one lot of shipped product per year must be
retained.
B The reserve sample should be at least twice the amount required for all tests required
to determine whether the active ingredient meets established specifications.
C Reserve samples should be stored under conditions equivalent to the product storage
conditions.
D Any evidence of reserve sample deterioration should be reported - Answer- A reserve
sample representative of one lot of shipped product per year must be retained.
All of the following would require a Type B Meeting request EXCEPT:
A Special Protocol Assessment SPA,
B PreIND,
C End of Phase 2,
D PreBLA - Answer- A
The Federal Trade Commission (FTC) has primary authority over which of the
following?
A Overthecounter OTC drug advertising ,
B Prescription drug advertising,
C Generic drug advertising,
D Restricted edical device advertising - Answer- Overthecounter OTC drug advertising
Senior management at your company asked you to develop a justification for fast track
status for an investigational new drug or epilepsy. Which of the following would be an
appropriate justification for FDA granting fast track status for this
investigational new drug?
A preliminary evidence of effectiveness was seen in the principal controlled trials
intended to provide evidence of effectiveness
B Epilepsy is considered by FDA to be a serious disease
C Pharmacokinetic profile of the new drug indicates less potential for toxic drug-drug
interactions with other anticonvulsant
medications
D Answers A B and C - Answer- D
, Your company recently submitted a Biologics License Application (BLA) to CDER and
the review division has notified you that you must develop and submit a Medication
Guide. This request may have resulted from any of the following EXCEPT: - Answer-
The product is one that has been demonstrated through adequate and well-controlled
trials to be less effective than
alternative therapies
A medical device manufacturer is preparing a submission that requires a Declaration of
Conformity with design control requirements. What type of submission is the
manufacturer preparing to submit to FDA? - Answer- An Abbreviated 510(k)
When should the manufacturer of a Class III medical device expect to have an FDA
establishment registration inspection? - Answer- Prior to approval of the PMA
During a periodic visit to a clinical investigator, the study monitor should assure all of the
following EXCEPT:
A Informed consent has been documented in subjects
B The study protocol is being followed.
C The investigator has assigned activities in the protocol to other staff.
D Changes to the protocol have been approved - Answer- The investigator has
assigned activities in the protocol to other staff.
A company is planning to develop a sunscreen with an ingredient consistent with its
published monograph for marketing within the US. What type of filing does the company
have to submit - Answer- OTC Application
At what timeframe after submitting an NDA will FDA provide the organization with an
opportunity to meet with agency reviewing officials to inform applicants of the general
progress and status of their application? - Answer- 90-day conference
A medical device may be exported under Section 801(e) of the Food, Drug, and
Cosmetic Act provided that all of the following apply for the device EXCEPT:
A It is in accordance with the specifications f the receiving country,
B It is not in conflict with the laws of the recieving country ,
C It is 510k cleared or PMA approved,
D It is labeled on the outside of the shipping carton for export to the receiving country. -
Answer- It is 510(k) cleared or PMA approved
Which of the following is NOT true for an FDA inspection of a manufacturing facility?
A notice of inspection FDA 482 form is presented to the facility upon arrival,
B The credentials of the FDA investigator can be photocopied for filing at the facility.
C The FDA investigator provides inspectional report with the FDA 483 form,
D The FDA investigator provides an FDA 484 form to describe samples taken during the
inspection. - Answer- The credentials of the FDA investigator can be photocopied for
filing at the facility.
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