RAC- Final exam – Regulatory Affairs Certification Drugs
Practice EXAM LATEST 600 QUESTIONS AND 100%
Verified ANSWERS JUST RELEASED
The Food and Drug Administration Amendments Act of 2007 (FDAAA) established all of the following
EXCEPT:
A. Expanded FDA authority for postmarket safety of drugs.
B. Reauthorization of prescription drug and medical device user fees.
C. Incentives to medical device manufacturers to create devices for children.
D. Voluntary registration of clinical trials in FDA database. - answer>>D. Voluntary registration of clinical
trials in FDA database.
FDAAA established mandatory registration of clinical trials in the ClinicalTrials.gov data bank.
Drug X is already approved for the treatment of blood cancer in the US. The manufacturer plans to
submit a New Drug Application (NDA) for the same drug to treat a new indication, which affects 50,000
women in the US. You are asked to consider whether this new NDA can be submitted under Orphan
Drug Designation (ODD). What will be your recommendation regarding ODD status?
A. The manufacturer can request an ODD since blood cancer affects 50,000 women in the US
B. The drug would be eligible for orphan status since it is a new orphan indication from the already
approved indication of blood cancer
C. The manufacturer can request ODD for the new indication and for the blood cancer use
D.The drug manufacturer can request ODD after setting up a meeting with FDA's Office of Orphan
Product development (OOPD) - answer>>B. The drug would be eligible for orphan status since it is a new
orphan indication from the already approved indication of blood cancer
A sponsor may request orphan drug designation of a previously unapproved drug or of a new orphan
indication for an already marketed drug.
One of the conditions for a drug product to be eligible for orphan status is that the drug should not be
the subject of a marketing application submitted prior to filing an orphan status request. FILE BEFORE
NDA
,Five-year exclusivity on a chemical compound, sometimes called New Chemical Entity (NCE) exclusivity,
prevents the approval of all of the following for five years EXCEPT:
A. A generic application for the approved active ingredient
B. A generic application for a salt of the approved active ingredient
C. A generic application for an ester of the approved active ingredient
D. A Section 505(b)(1) New Drug Application (NDA) for the same drug - answer>>D. A Section 505(b)(1)
New Drug Application (NDA) for the same drug
NCE exclusivity prevents the approval of a generic application for the approved active ingredient or any
salt or ester of the approved active ingredient for five years. However, five-year exclusivity does not
prevent FDA from approving, or a company from submitting, a full Section 505(b)(1) NDA for the same
drug.
A company is sponsoring a Phase 2 clinical study investigating a new drug for treatment of Disease X,
which currently affects 190,000 people in the US. Which of the following may a regulatory professional
take into consideration if senior management asks about requesting orphan drug designation?
A. The new drug would not be eligible for orphan drug designation given the number of people currently
affected by Disease X in the US
B. The company must demonstrate that Disease X is life-threatening for the new drug to be eligible for
orphan drug designation
C. Obtaining orphan drug designation is not possible since an IND has already been submitted
D. The company must request orphan drug designation before submitting a marketing application for
the new drug - answer>>D. The company must request orphan drug designation before submitting a
marketing application for the new drug
According to 21 CFR 316.23, "A sponsor may request orphan-drug designation at any time in the drug
development process prior to the submission of a marketing application for the drug product for the
orphan indication."
,The supply chain organization would like to qualify an alternate vendor for the drug substance utilized to
manufacture a drug product. Which question does NOT need to be asked in order to complete a
regulatory assessment?
A. Are the drug substance specifications changing?
B. Does the vendor have a US DMF for this material?
C. Where is the vendor located?
D. Has the site had a satisfactory GMP inspection by FDA? - answer>>C. Where is the vendor located?
To assess the regulatory impact and filing classification for this change, the answers for questions A, B
and D are all beneficial to the regulatory professional. Although certain regions of the world have
received additional attention from FDA, the location of the vendor is not needed to conduct the
analysis.
Which of the following is the best regulatory pathway for drugs containing similar active ingredients as a
previously approved drug for a new indication?
A. 505(j) ANDA
B. 505(b)(1) NDA
C. 505(b)(2) NDA
D. 505(d) Substantial Evidence of Effectiveness - answer>>C. 505(b)(2) NDA
An application that contains full reports of investigations of safety and effectiveness but where at least
some of the information required for approval comes from studies not conducted by or for the applicant
and for which the applicant has not obtained a right of reference (section 505(b)(2)); Following are
examples of changes to approved drugs for which 505(b)(2) applications should be submitted.
- Active ingredient. An application for a change in an active ingredient such as a different salt, ester,
complex, chelate, clathrate, racemate or enantiomer of an active ingredient in a listed drug containing
the same active moiety.
- Dosage form. An application for a change of dosage form, such as a change from a solid oral dosage
form to a transdermal patch that relies to some extent upon the Agency's finding of safety and/or
effectiveness for an approved drug.
Strength. An application for a change to a lower or higher strength.
, - Route of administration. An application for a change in the route of administration, such as a change
from an intravenous to intrathecal route.
Substitution of an active ingredient in a combination product. An application for a change in one of the
active ingredients of an approved combination product for another active ingredient that has or has not
been previously approved.
In order to be approved by FDA, a generic drug must be therapeutically equivalent to the branded
product with the exception of:
A. Dosage Form
B. Route of Administration
C. Inactive Ingredient(s)
D. Labeling - answer>>C. Inactive Ingredient(s)
The law requires that generic drugs approved by FDA have the same active ingredient(s), dosage form,
strength, route of administration, labeling, and conditions for use as the branded product, and that the
generic and branded drug be bioequivalent. The inactive ingredients can be different. Sec. 314.92 Drug
products for which abbreviated applications may be submitted.
For determining the suitability of an abbreviated new drug application, the term "same as" means
identical in active ingredient(s), dosage form, strength, route of administration, and conditions of use,
except that conditions of use for which approval cannot be granted because of exclusivity or an existing
patent may be omitted.
Phase 2 clinical trials are being planned for a novel cancer drug. All of the following are appropriate
factors in this phase of the study EXCEPT:
A. Enrollment of cancer patients
B. Enrollment of healthy subjects
C. Study of one or more indications
D Collection of efficacy data - answer>>B. Enrollment of healthy subjects
Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a
particular indication or indications in patients with the disease or condition under study, to determine
Practice EXAM LATEST 600 QUESTIONS AND 100%
Verified ANSWERS JUST RELEASED
The Food and Drug Administration Amendments Act of 2007 (FDAAA) established all of the following
EXCEPT:
A. Expanded FDA authority for postmarket safety of drugs.
B. Reauthorization of prescription drug and medical device user fees.
C. Incentives to medical device manufacturers to create devices for children.
D. Voluntary registration of clinical trials in FDA database. - answer>>D. Voluntary registration of clinical
trials in FDA database.
FDAAA established mandatory registration of clinical trials in the ClinicalTrials.gov data bank.
Drug X is already approved for the treatment of blood cancer in the US. The manufacturer plans to
submit a New Drug Application (NDA) for the same drug to treat a new indication, which affects 50,000
women in the US. You are asked to consider whether this new NDA can be submitted under Orphan
Drug Designation (ODD). What will be your recommendation regarding ODD status?
A. The manufacturer can request an ODD since blood cancer affects 50,000 women in the US
B. The drug would be eligible for orphan status since it is a new orphan indication from the already
approved indication of blood cancer
C. The manufacturer can request ODD for the new indication and for the blood cancer use
D.The drug manufacturer can request ODD after setting up a meeting with FDA's Office of Orphan
Product development (OOPD) - answer>>B. The drug would be eligible for orphan status since it is a new
orphan indication from the already approved indication of blood cancer
A sponsor may request orphan drug designation of a previously unapproved drug or of a new orphan
indication for an already marketed drug.
One of the conditions for a drug product to be eligible for orphan status is that the drug should not be
the subject of a marketing application submitted prior to filing an orphan status request. FILE BEFORE
NDA
,Five-year exclusivity on a chemical compound, sometimes called New Chemical Entity (NCE) exclusivity,
prevents the approval of all of the following for five years EXCEPT:
A. A generic application for the approved active ingredient
B. A generic application for a salt of the approved active ingredient
C. A generic application for an ester of the approved active ingredient
D. A Section 505(b)(1) New Drug Application (NDA) for the same drug - answer>>D. A Section 505(b)(1)
New Drug Application (NDA) for the same drug
NCE exclusivity prevents the approval of a generic application for the approved active ingredient or any
salt or ester of the approved active ingredient for five years. However, five-year exclusivity does not
prevent FDA from approving, or a company from submitting, a full Section 505(b)(1) NDA for the same
drug.
A company is sponsoring a Phase 2 clinical study investigating a new drug for treatment of Disease X,
which currently affects 190,000 people in the US. Which of the following may a regulatory professional
take into consideration if senior management asks about requesting orphan drug designation?
A. The new drug would not be eligible for orphan drug designation given the number of people currently
affected by Disease X in the US
B. The company must demonstrate that Disease X is life-threatening for the new drug to be eligible for
orphan drug designation
C. Obtaining orphan drug designation is not possible since an IND has already been submitted
D. The company must request orphan drug designation before submitting a marketing application for
the new drug - answer>>D. The company must request orphan drug designation before submitting a
marketing application for the new drug
According to 21 CFR 316.23, "A sponsor may request orphan-drug designation at any time in the drug
development process prior to the submission of a marketing application for the drug product for the
orphan indication."
,The supply chain organization would like to qualify an alternate vendor for the drug substance utilized to
manufacture a drug product. Which question does NOT need to be asked in order to complete a
regulatory assessment?
A. Are the drug substance specifications changing?
B. Does the vendor have a US DMF for this material?
C. Where is the vendor located?
D. Has the site had a satisfactory GMP inspection by FDA? - answer>>C. Where is the vendor located?
To assess the regulatory impact and filing classification for this change, the answers for questions A, B
and D are all beneficial to the regulatory professional. Although certain regions of the world have
received additional attention from FDA, the location of the vendor is not needed to conduct the
analysis.
Which of the following is the best regulatory pathway for drugs containing similar active ingredients as a
previously approved drug for a new indication?
A. 505(j) ANDA
B. 505(b)(1) NDA
C. 505(b)(2) NDA
D. 505(d) Substantial Evidence of Effectiveness - answer>>C. 505(b)(2) NDA
An application that contains full reports of investigations of safety and effectiveness but where at least
some of the information required for approval comes from studies not conducted by or for the applicant
and for which the applicant has not obtained a right of reference (section 505(b)(2)); Following are
examples of changes to approved drugs for which 505(b)(2) applications should be submitted.
- Active ingredient. An application for a change in an active ingredient such as a different salt, ester,
complex, chelate, clathrate, racemate or enantiomer of an active ingredient in a listed drug containing
the same active moiety.
- Dosage form. An application for a change of dosage form, such as a change from a solid oral dosage
form to a transdermal patch that relies to some extent upon the Agency's finding of safety and/or
effectiveness for an approved drug.
Strength. An application for a change to a lower or higher strength.
, - Route of administration. An application for a change in the route of administration, such as a change
from an intravenous to intrathecal route.
Substitution of an active ingredient in a combination product. An application for a change in one of the
active ingredients of an approved combination product for another active ingredient that has or has not
been previously approved.
In order to be approved by FDA, a generic drug must be therapeutically equivalent to the branded
product with the exception of:
A. Dosage Form
B. Route of Administration
C. Inactive Ingredient(s)
D. Labeling - answer>>C. Inactive Ingredient(s)
The law requires that generic drugs approved by FDA have the same active ingredient(s), dosage form,
strength, route of administration, labeling, and conditions for use as the branded product, and that the
generic and branded drug be bioequivalent. The inactive ingredients can be different. Sec. 314.92 Drug
products for which abbreviated applications may be submitted.
For determining the suitability of an abbreviated new drug application, the term "same as" means
identical in active ingredient(s), dosage form, strength, route of administration, and conditions of use,
except that conditions of use for which approval cannot be granted because of exclusivity or an existing
patent may be omitted.
Phase 2 clinical trials are being planned for a novel cancer drug. All of the following are appropriate
factors in this phase of the study EXCEPT:
A. Enrollment of cancer patients
B. Enrollment of healthy subjects
C. Study of one or more indications
D Collection of efficacy data - answer>>B. Enrollment of healthy subjects
Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a
particular indication or indications in patients with the disease or condition under study, to determine
