Exam (elaborations)
RAC Practice Exam 1 Questions and Answers
- Institution
- RAC Practice Exam 1 Questions And Answers
RAC Practice Exam 1 Questions and Answers
[Show more]
Content preview
RAC Practice Exam 1 Questions and AnswersWhich 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 - -A.
-The final authority for ensuring the adequacy of an Investigational New
Drug (IND) informed consent document resides with the: - -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? - -Suitability Petition
-A 505(b)(2) NDA is not an appropriate regulatory submission for the
approval to market a - -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: - -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? - -14 days
-Adverse event reporting for a marketed biologics product is NOT required
for: - -Diagnostic non-invasive test kits
-The quality assurance manager of a small company consisting of 12
employees is the only internal auditor for the company and has been
performing all internal quality system audits for three years. This does not
meet the requirements for performing internal quality systems audits
because - -Auditor independence has not been ensured.
, -You have modified your 510(k)-cleared device with a Special 510(k). In
which case would a Special 510(k) not be appropriate for the device? - -You
have changed the primary mechanism of action.
-Which Premarket Approval Application (PMA) supplements are NOT subject
to user fee exemption? - -Real Time Supplement
-A medical device company allows its sales force to maintain a product
inventory in the field. The device has an expiration date indicated on its
labeling. A sales person notes that one of his products has expired and
contacts the headquarters office for direction. He is told to return the product
to the headquarter office for replacement. The return of this product is
considered as what type of recall? - -Not a recall—it is considered normal
stock rotation
-A company is developing an (unapproved) drug-device combination product
but is not sure to which center it should submit its marketing application. The
company should first submit - -A Request for Designation to the Office of
Combination Products
-A medical device company is developing a product with drug, biologic and
device components. The product and indication have not been previously
classified by FDA. What is the most appropriate regulatory pathway? - -A
Request for Designation (RFD) should be sent to the Office of Combination
Products (OCP) at FDA to determine the primary mode of action (PMOA) and
assign the agency with primary jurisdiction.
-FDA's Office of Generic Drugs (OGD) remains committed to the "first-in,
first-reviewed" review order for the reviewing original Abbreviated New Drug
Applications (ANDAs), amendments and supplements unless there is a
specific reason to expedite an application. What is NOT a specific reason to
grant expedited review? - -Products that show evidence of safety and
effectiveness in a new subpopulation
-A firm is preparing a 510(k), premarket notification to FDA for an in vitro
diagnostic test, a microhematocrit analyzer that, among other intended uses,
can determine the hematocrit of a blood donor prior to donation of a blood
product. The firm should address the 510(k) submission to: - -CBER
-Notice of Intent to Revoke license can be issued for the following reason,
EXCEPT
A Unable to gain access to the manufacturing plant,
B Licensed product are no longer safe and effective
C Failure to report serious adverse event,
D Manufacturer fails to conform to applicable standards - -C
, -What is the formal early collaboration meeting that was implemented
through the Food and Drug Modernization Act (FDAMA)? - -Agreement
Meeting
The Agreement Meeting is a formal meeting to agree upon the parameters of
the investigational plan. When a meeting
request is received by FDA, the meeting will be held within 30 days. The
agreements made at the meeting are provided in writing to the sponsor and
are binding on FDA. Regulatory Reference: Early Collaboration Meetings
Under the FDA Modernization Act; Final Guidance for Industry and for CDRH
Staff (February 2001).
-A US medical device contract manufacturer has customers for whom it
manufactures medical device components (parts) and finished medical
devices. To date, all products have been either parts for Class II medical
devices or Class II finished medical devices. The manager of new business
contacts the regulatory manager to assess the impact of a possible new
customer
involving a Class III device. What is the first question the regulatory manager
should ask in order to begin assessing the impact of Class III on plant
operations? - -Is it a component or device that would be manufactured?
-The following biological products are regulated by CBER EXCEPT:
A Immunizing toxoids,
B Monoclonal antibodies for in vitro use,
C Monoclonal antibodies for in vivo use,
D Infusion of animal sourced cells into a hum - -B
-You work for a company that is developing an autologous cellular therapy
product. FDA has informed your company that your product will be regulated
as a HCT/P (Human Cells, Tissues and Cellular and Tissue-Based Product).
Based on this information, which of the following regulatory requirements
will your company need to be compliant with when manufacturing
the product? - -All Subparts of 21 CFR 1271 except Subpart C (Donor
Eligibility)
-A company has submitted its NDA for review. An NDA amendment can be
submitted to change or add information to a not yet-
approved NDA. When must new safety information be submitted in a safety
update report? - -Four months after the initial NDA submission (120 day
safety update)
-A television advertisement that you have been asked to review prior to
release discusses the benefits of the drug in detail for 25 seconds, and then
names all the major side effects associated with the product in the last five
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 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 £10.19. 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 revision notes and other study material for 14 years now