RAC-Drugs Regulatory Affairs Certification Practice
Final EXAM LATEST 600 QUESTIONS AND 100% Verified
ANSWERS JUST RELEASED
Which of the following are NOT required to be included in a Request for Designation (RFD) for a
combination product?
A. The product's proprietary name
B. Process validation protocols and reports
C. Chemical, physical or biological composition
D. The sponsor's identity - answer>>B. Process validation protocols and reports
Process validation protocols and reports are not required to be submitted as part of the RFD.
While reviewing product complaint files for MDR reportability, you noticed a complaint regarding a
common failure mode of an implantable screw. There was no patient involvement and no adverse
consequences were reported in the complaint. Your firm has initiated a Class I recall for this
implantable screw due to safety issues associated with this failure mode. As a regulatory professional
your decision is:
A. This complaint is reportable; an MDR will be filed with FDA within 30 days
B. A review of the complaint history is needed to see whether such failure mode will likely cause or
contribute to death or serious injury
C. No MDR is needed as there is no patient involvement and no adverse consequences were reported
D. No MDR is needed but you will file this complaint in the recall file - answer>>A. This complaint is
reportable; an MDR will be filed with FDA within 30 days
When a recall is initiated for a particular product failure mode, such failure mode is automatically
MDR-reportable to FDA. Additionally, while the complaint did not report an adverse event, the
manufacturer should evaluate the potential to cause an adverse event if the failure mode was to re-
occur.
,Company Z selected a proprietary name for its new molecular entity, currently in development. The
NDA will be submitted in six months. All of the following are relevant to the proprietary name EXCEPT:
A. The request for proprietary name approval may be submitted with the NDA.
B. The proprietary name submission package may be submitted up to one month after NDA
submission.
C. The request for proprietary name approval may be submitted prior to the NDA.
D. FDA will inform the applicant prior to the action date whether the proprietary name is acceptable. -
answer>>B. The proprietary name submission package may be submitted up to one month after NDA
submission.
The request for proprietary name approval must be submitted no later than in the NDA. Companies
have the option of submitting a proprietary name request prior to NDA submission under the
Investigational New Drug application (IND). FDA review of proprietary names evaluates both the
proposed names' safety and promotional aspects. FDA will inform the applicant prior to the action
date whether the proprietary name is acceptable and will offer suggestions if the proposed name is
deemed unacceptable.
Sec. 314.50 Content and format of an application.
(a)Application form. The applicant shall submit a completed and signed application form that contains
the following:
(1) The name and address of the applicant; the date of the application; the application number if
previously issued (for example, if the application is a resubmission, an amendment, or a supplement);
the name of the drug product, including its established, proprietary, code, and chemical names;
A sponsor intends to submit a Special Protocol Assessment (SPA) request for a clinical trial that will
form the primary basis of an efficacy claim in an NDA. Which of the following is TRUE?
A. The sponsor should submit the SPA request within 30 days following the start of the trial to expedite
FDA feedback
B. An SPA provides an opportunity to focus on general drug development issues
C. The SPA request will be handled as a request for a Type B meeting
,D. A sponsor can submit a revised protocol while the agency is reviewing an earlier version of the same
protocol - answer>>D. A sponsor can submit a revised protocol while the agency is reviewing an earlier
version of the same protocol
The agency can communicate with the sponsor regarding the protocol before issuing a Special Protocol
Assessment letter. In such cases, the sponsor can choose to submit a revised protocol. If a sponsor
submits a revised protocol, for any reason, while the agency is reviewing an earlier version of the same
protocol, FDA ordinarily will not respond to the questions posed about the earlier version of the
protocol and will consider the original request withdrawn. The agency will consider a request for a
Special Protocol Assessment of a revised protocol to be a new request and will act on the revised
protocol within 45 days.
A 505(b)(2) NDA is NOT an appropriate regulatory submission for the approval to market a:
A. New Chemical Entity when FDA relies for approval on data not developed by the applicant
B. Different route of administration for an approved product
C. Combination of two active ingredients that have been approved individually
D. New Chemical Entity when the sponsor has a right of reference to all applicable published studies -
answer>>D. New Chemical Entity when the sponsor has a right of reference to all applicable published
studies
A 505(b)2 NDA is an application where approval of the new drug relies on data at least in part that is
not developed by the applicant.
505(b)(2) Application means an application submitted under section 505(b)(1) of the act for a drug for
which the investigations described in section 505(b)(1)(A) of the act
and relied upon by the applicant for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or use from the person by
or for whom the investigations were conducted.
An important consideration in developing 505(b)(2) products as compared to ANDA products is:
A. Lower costs of 505(b)(2) regulated product development and review.
, B. Extended market exclusivity of 505(b)(2) products.
C. Faster FDA processing and approval times for 505(b)(2) products.
D. Product development costs and FDA review times for 505(b)(2) products. - answer>>B. Extended
market exclusivity of 505(b)(2) products.
For 505(b)(2) products, there are three to five years of market exclusivity in the US, depending on the
extent of changes to the previously approved drug and the amount of data submitted to FDA. This is an
apparent advantage when compared to ANDA approval, where exclusivity can be held for only 180
days and applies only to the first generic product.
A 505(b)(2) application may itself be granted three years of Waxman-Hatch exclusivity if one or more
of the clinical investigations, other than BA/BE studies, was essential to
approval of the application and was conducted or sponsored by the applicant (21 CFR 314.50(j);
314.108(b)(4) and (5)). A 505(b)(2) application also be granted five years of exclusivity if it is for a new
chemical entity (21 CFR 314.50(j); 314.108(b)(2)). A 505(b)(2) application also may be eligible for
orphan drug exclusivity (21 CFR 314.20- 316.36) or pediatric exclusivity (section 505A of the act).
A sponsor has an approved product that has been marketed for several years and contains a
preservative. However, the product has been reformulated to remove the preservative and the
sponsor conducted new clinical trials essential to support approval of the new application. Does the
sponsor qualify for exclusivity for the product?
A. No, the sponsor does not qualify for exclusivity.
B. Yes, the sponsor qualifies for 180-day exclusivity.
C. Yes, the sponsor qualifies for three-year exclusivity.
D. Yes, the sponsor qualifies for five-year exclusivity. - answer>>C. Yes, the sponsor qualifies for three-
year exclusivity.
The Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984) provides for
patent term extensions. Under the amendment to the FD&C Act, a
sponsor may qualify for three-year exclusivity if the following criteria are met: the active moiety must
have been the subject of an approved application, the new application (defined as a full NDA, BLA,
505(b)(2) or a supplement to any application mentioned) must contain new clinical trial data that are
Final EXAM LATEST 600 QUESTIONS AND 100% Verified
ANSWERS JUST RELEASED
Which of the following are NOT required to be included in a Request for Designation (RFD) for a
combination product?
A. The product's proprietary name
B. Process validation protocols and reports
C. Chemical, physical or biological composition
D. The sponsor's identity - answer>>B. Process validation protocols and reports
Process validation protocols and reports are not required to be submitted as part of the RFD.
While reviewing product complaint files for MDR reportability, you noticed a complaint regarding a
common failure mode of an implantable screw. There was no patient involvement and no adverse
consequences were reported in the complaint. Your firm has initiated a Class I recall for this
implantable screw due to safety issues associated with this failure mode. As a regulatory professional
your decision is:
A. This complaint is reportable; an MDR will be filed with FDA within 30 days
B. A review of the complaint history is needed to see whether such failure mode will likely cause or
contribute to death or serious injury
C. No MDR is needed as there is no patient involvement and no adverse consequences were reported
D. No MDR is needed but you will file this complaint in the recall file - answer>>A. This complaint is
reportable; an MDR will be filed with FDA within 30 days
When a recall is initiated for a particular product failure mode, such failure mode is automatically
MDR-reportable to FDA. Additionally, while the complaint did not report an adverse event, the
manufacturer should evaluate the potential to cause an adverse event if the failure mode was to re-
occur.
,Company Z selected a proprietary name for its new molecular entity, currently in development. The
NDA will be submitted in six months. All of the following are relevant to the proprietary name EXCEPT:
A. The request for proprietary name approval may be submitted with the NDA.
B. The proprietary name submission package may be submitted up to one month after NDA
submission.
C. The request for proprietary name approval may be submitted prior to the NDA.
D. FDA will inform the applicant prior to the action date whether the proprietary name is acceptable. -
answer>>B. The proprietary name submission package may be submitted up to one month after NDA
submission.
The request for proprietary name approval must be submitted no later than in the NDA. Companies
have the option of submitting a proprietary name request prior to NDA submission under the
Investigational New Drug application (IND). FDA review of proprietary names evaluates both the
proposed names' safety and promotional aspects. FDA will inform the applicant prior to the action
date whether the proprietary name is acceptable and will offer suggestions if the proposed name is
deemed unacceptable.
Sec. 314.50 Content and format of an application.
(a)Application form. The applicant shall submit a completed and signed application form that contains
the following:
(1) The name and address of the applicant; the date of the application; the application number if
previously issued (for example, if the application is a resubmission, an amendment, or a supplement);
the name of the drug product, including its established, proprietary, code, and chemical names;
A sponsor intends to submit a Special Protocol Assessment (SPA) request for a clinical trial that will
form the primary basis of an efficacy claim in an NDA. Which of the following is TRUE?
A. The sponsor should submit the SPA request within 30 days following the start of the trial to expedite
FDA feedback
B. An SPA provides an opportunity to focus on general drug development issues
C. The SPA request will be handled as a request for a Type B meeting
,D. A sponsor can submit a revised protocol while the agency is reviewing an earlier version of the same
protocol - answer>>D. A sponsor can submit a revised protocol while the agency is reviewing an earlier
version of the same protocol
The agency can communicate with the sponsor regarding the protocol before issuing a Special Protocol
Assessment letter. In such cases, the sponsor can choose to submit a revised protocol. If a sponsor
submits a revised protocol, for any reason, while the agency is reviewing an earlier version of the same
protocol, FDA ordinarily will not respond to the questions posed about the earlier version of the
protocol and will consider the original request withdrawn. The agency will consider a request for a
Special Protocol Assessment of a revised protocol to be a new request and will act on the revised
protocol within 45 days.
A 505(b)(2) NDA is NOT an appropriate regulatory submission for the approval to market a:
A. New Chemical Entity when FDA relies for approval on data not developed by the applicant
B. Different route of administration for an approved product
C. Combination of two active ingredients that have been approved individually
D. New Chemical Entity when the sponsor has a right of reference to all applicable published studies -
answer>>D. New Chemical Entity when the sponsor has a right of reference to all applicable published
studies
A 505(b)2 NDA is an application where approval of the new drug relies on data at least in part that is
not developed by the applicant.
505(b)(2) Application means an application submitted under section 505(b)(1) of the act for a drug for
which the investigations described in section 505(b)(1)(A) of the act
and relied upon by the applicant for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or use from the person by
or for whom the investigations were conducted.
An important consideration in developing 505(b)(2) products as compared to ANDA products is:
A. Lower costs of 505(b)(2) regulated product development and review.
, B. Extended market exclusivity of 505(b)(2) products.
C. Faster FDA processing and approval times for 505(b)(2) products.
D. Product development costs and FDA review times for 505(b)(2) products. - answer>>B. Extended
market exclusivity of 505(b)(2) products.
For 505(b)(2) products, there are three to five years of market exclusivity in the US, depending on the
extent of changes to the previously approved drug and the amount of data submitted to FDA. This is an
apparent advantage when compared to ANDA approval, where exclusivity can be held for only 180
days and applies only to the first generic product.
A 505(b)(2) application may itself be granted three years of Waxman-Hatch exclusivity if one or more
of the clinical investigations, other than BA/BE studies, was essential to
approval of the application and was conducted or sponsored by the applicant (21 CFR 314.50(j);
314.108(b)(4) and (5)). A 505(b)(2) application also be granted five years of exclusivity if it is for a new
chemical entity (21 CFR 314.50(j); 314.108(b)(2)). A 505(b)(2) application also may be eligible for
orphan drug exclusivity (21 CFR 314.20- 316.36) or pediatric exclusivity (section 505A of the act).
A sponsor has an approved product that has been marketed for several years and contains a
preservative. However, the product has been reformulated to remove the preservative and the
sponsor conducted new clinical trials essential to support approval of the new application. Does the
sponsor qualify for exclusivity for the product?
A. No, the sponsor does not qualify for exclusivity.
B. Yes, the sponsor qualifies for 180-day exclusivity.
C. Yes, the sponsor qualifies for three-year exclusivity.
D. Yes, the sponsor qualifies for five-year exclusivity. - answer>>C. Yes, the sponsor qualifies for three-
year exclusivity.
The Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984) provides for
patent term extensions. Under the amendment to the FD&C Act, a
sponsor may qualify for three-year exclusivity if the following criteria are met: the active moiety must
have been the subject of an approved application, the new application (defined as a full NDA, BLA,
505(b)(2) or a supplement to any application mentioned) must contain new clinical trial data that are
