Which of the following is NOT required for compliance under 21 CFR Part 11
(electronic records and electronic signatures)?
A Manually generated timestamped audit trails to record the date and time of
operator entries and actions that create, modify or delete electronic records.
B Validation of systems to ensure accuracy
C Authority checks to ensure that only authorized personell can create, modify or
delete electronic records.
D Establishment of and adherence to written procedures - ANSWER A.
The final authority for ensuring the adequacy of an Investigational New Drug
(IND) informed consent document resides with the: - ANSWER Institutional
Review Board (IRB)
A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug
product that varies from the Reference Listed Drug (RLD) in route of
administration, dosage form, or strength, but anticipates that the labeling will be
identical to that of the RLD. What process should be used to apply for that
permission from FDA? - ANSWER Suitability Petition
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to
market a - ANSWER New chemical entity when the sponsor has a right of
reference to all applicable published studies
Distribution records for drug products must reference or contain: - ANSWER
Name and address of the consignee
A mid-sized pharmaceutical company negotiated with FDA to submit a draft
Package Insert (PI) and patient medication guide (MedGuide) in annotated Word
format for initial FDA review, and committed to submit the Labeling in Structured
Product Label
(SPL) format upon approval of their product. What is the preferred timeline for
this pharmaceutical company to submit the SPL formatted labeling upon product
approval? - ANSWER 14 days
Adverse event reporting for a marketed biologics product is NOT required for: -
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