RAC Practice Exam 1 2024 | 93
Questions with 100% Correct Answers |
Verified | Latest Update 2024| Graded A+
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 seconds. You should
advise that: - ✔✔The benefits and side effects of the drug should be
presented with the same level of scope, depth and detail.
, At the completion of a Preapproval Inspection where a deficiency was noted, a
meeting is convened to discuss what document? - ✔✔Form FDA 483
Due to market interest, a new strength for an existing combination OTC product
for use in the adult population (labeled as 12 years of age and older) has been
developed, and appropriate data have been gathered to support safety and
efficacy. The existing product is regulated by a final monograph, but does not
contain labeling for use of the new strength in adult populations. What options
could the company utilize to modify the monograph in order to gain FDA approval
to market the new dosing regimen? - ✔✔New Drug Application; Citizen's
Petition; and Time and Extent Application
If a company is planning to market a medical device that is substantially equivalent
to a device marketed before 1976, it can use which regulatory path? -
✔✔510(k)
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