RAC Drugs Practice Exam Questions With
Correct Answers
One |month |prior |to |the |anticipated |approval |date |for |your |product, |the |marketing |application |
that |you |submitted |to |a |major |regulatory |authority |has |become |the |subject |of |an |advisory |
committee |meeting |of |experts |convened |by |the |regulatory |authority. |The |advisory |committee |
members |unanimously |vote |not |to |approve |your |product |because |of |a |safety |concern. |Two |
days |after |the |advisory |committee |meeting, |the |regulatory |authority |requests |additional |
information |to |support |the |safety |of |your |product. |Assuming |you |have |no |additional |data |to |
provide, |which |of |the |following |would |be |your |MOST |appropriate |response |to |the |regulatory |
authority's |request?
See |next |card
1. |"Given |the |advisory |committee's |unanimous |decision, |we |know |that |the |product |will |not |be
|approved, |and |additional |data |will |not |make |any |difference.
2. |"We |have |no |additional |information |to |provide |at |this |time, |but |we |can |perform |an |
additional |analysis |for |a |specific |safety |concern, |if |necessary."
3. |"We |disagree |with |the |advisory |committee's |decision |because |the |committee |neglected |the
|thorough |safety |analysis |that |we |provided."
4. |"We |have |no |additional |information |to |provide |at |this |time |because |we |have |already |
provided |everything |needed |to |support |our |product's |approval."
2. |We |have |no |additional |information |to |provide |at |this |time, |but |we |can |perform |an |
additional |analysis |for |a |specific |safety |concern, |if |necessary
Which |of |the |following |responsibilities |is |specifically |assigned |to |the |Qualified |Person |(QP) |
during |the |batch |release |process?
1. |The |QP |must |ensure |that |all |manufacturing |processes |are |completed |before |batch |release.
2. |The |QP |is |tasked |with |verifying |that |the |batch |meets |the |specifications |outlined |in |the |
Marketing |Authorization.
3. |The |QP |is |responsible |for |conducting |clinical |trials |for |the |product.
4. |The |QP |must |oversee |the |marketing |strategies |for |the |product.
2. |The |QP |is |tasked |with |verifying |that |the |batch |meets |the |specifications |outlined |in |the |
Marketing |Authorization
What |is |the |required |duration |of |continuous |administration |in |months |that |necessitates |the |
evaluation |of |carcinogenic |potential |for |pharmaceutical |products?
,1. |3 |moths
2. |6 |months
3. |12 |months
4. |24 |months
2. |6 |months
A |sponsor |is |planning |to |initiate |a |pivotal |clinical |study |for |a |drug-lead |combination |product |
(e.g. |prefilled |syringe, |autoinjector, |etc.). |For |the |device |constituent |of |the |combination |
product, |what's |the |FDA |minimum |regulatory |requirement |that |must |be |met |prior |to |
introducing |the |combination |product |into |the |clinical |study?
1. |Meet |combination |product |cGMP |requirements
2. |Meet |the |usability |human |factors |requirement.
3. |Meet |the |design |controls |requirement |according |to |21 |CFR |part |820.30, |unless |the |device |
constituent |is |exempt |from |design |controls |requirements.
4. |Meet |the |EU |MDR |General |Safety |and |Performance
3. |Meet |the |design |controls |requirement |according |to |21 |CFR |Part |820.30, |unless |the |device |
constituent |is |exempt |from |design |controls |requirements.
Which |of |the |following |is |false |regarding |FDA |expedited |programs?
1. |The |level |of |evidence |required |for |Fast |Track |Designation |is |less |than |for |Breakthrough |
Therapy |Designation?
2. |Breakthrough |Therapy |Designation |and |RMAT |Designation |require |evidence |that |the |drug |
may |offer |a |substantial |improvement |relative |to |available |therapies.
3. |RMAT |Designation |should |be |requested |with |the |IND |or |later, |but |no |later |than |the |EOP2 |
meeting.
4. |Fast |Track |Designation, |Breakthrough |Therapy |Designation, |and |RMAT |Designation |may |be |
rescinded |later |in |product |development.
2. |Breakthrough |Therapy |Designation |and |RMAT |Designation |require |evidence |that |the |drug |
may |offer |a |substantial |improvement |relative |to |available |therapies.
You |are |a |manufacturer |in |the |US, |and |you |discover |that |your |company's |top |selling |product |
in |the |last |two |years |has |been |used |off-label. |The |off-label |use |is |estimated |to |be |about |70%, |
and |it |has |been |consistent |since |the |product |was |first |released |to |the |market. |Which |of |the |
following |is |the |MOST |appropriate |next |step?
,1. |file |a |report |to |regulatory |authorities |and |advise |the |marketing |department |to |prevent |
future |off-label |use.
2. |Discuss |with |regulatory |authorities |to |investigate |how |to |have |the |off-label |indication |
approved.
3. |Discuss |the |off-label |use |with |Key |Opinion |leaders |(KOLs) |to |determine |how |many |patients |
would |benefit |from |the |approval |of |the |drug.
5. |No |action |is |required |since |it |is |an |off-label |use. |clinicians |have |the |freedom |to |treat |their |
patients |based |on |what |is |medically |appropriate.
2. |Discuss |with |regulatory |authorities |to |investigate |how |to |have |the |off-label |indication |
approved.
In |the |EU, |which |type |of |documentation |should |NOT |be |included |in |Module |1 |of |a |submitted |
dossier?
1. |SmPC, |Labeling, |and |Package |leaflet.
2. |Environmental |Risk |Assessment.
3. |Quality |overall |summary
4. |Risk |management |plan
3. |Quality |Overall |Summary
To |obtain |approval |for |an |ANDA, |a |company |MUST |meet |which |criterion?
1. |Submit |and |receive |approval |for |an |IND
2. |Demonstrate |safety |and |efficacy |of |the |proposed |generic |drug
3. |Demonstrate |bioequivalence |between |the |innovator |drug |and |the |proposed |generic |drug.
4. |Demonstrate |the |efficacy |of |the |innovator |drug |and |the |proposed |generic.
3. |Demonstrate |bioequivalence |between |the |innovator |drug |and |the |proposed |generic |drug
A |firm |is |preparing |a |501(k), |premarket |notification |to |FDA |for |an |in |vitro |diagnostic |test, |a |
microhematocrit |analyzer |that, |among |other |intended |uses, |can |determine |a |blood |donor's |
hematocrit |prior |to |donation. |The |firm |should |address |the |501(k) |submission |to:
1. |CDER
2. |CBER
3. |CDRH
4. |OCP
3. |CDRH
, During |the |review |of |a |company's |NDA |submission |by |the |FDA, |a |new |guideline |is |released |by |
the |FDA |that |affects |the |labeling |requirements |for |the |product. |What |should |the |regulatory |
professional |do |in |response |to |this |change?
1. |Revise |the |labeling |immediately |and |resubmit |to |the |FDA.
2. |Document |the |change |and |address |it |in |the |next |annual |report.
3. |Ignore |the |guideline |as |the |NDA |is |already |under |review.
4. |Consult |with |the |FDA |to |determine |if |a |supplemental |submission |is |necessary.
4. |Consult |with |the |FDA |to |determine |if |a |supplemental |submission |is |necessary.
A |company |is |developing |an |unapproved |cell |and |gene |therapy |that |is |a |combination |product |
(device-biologic). |What |application |and |to |which |center |should |the |company |submit |its |
application |for |marketing |approval?
1. |Submit |a |Premarket |Notification |application |to |CDRH.
2. |Submit |a |Biologic |License |Application |(BLA) |to |CDER
3. |Submit |a |BLA |to |CBER
4. |Submit |an |Investigational |New |Drug |Application |(IND) |tp |CBER
3. |Submit |a |Biologic |License |Application |to |CBER
Which |of |the |following |labeling |elements |is |NOT |required |for |all |over-the-counter |drugs |in |the
|U.S.?
1. |Name |and |place |of |business |of |manufacturer, |packer, |or |distributor?
2. |Net |quantity |of |contents.
3. |Statement |of |ingredients
4. |Pregnancy/breast-feeding |warning.
1. |Name |and |place |of |business |of |manufacturer, |packer, |or |distributor?
Which |of |the |following |is |not |classified |as |an |"Off-label" |use:
1. |A |patient |is |prescribed |an |approved |drug |that |was |deemed |safe |and |effective |for |a |different
|disease |indication.
2. |A |patient |is |prescribed |an |approved |drug |at |a |different |dosage |other |than |the |approved |
label.
3. |A |patient |is |prescribed |a |drug |that |was |approved |as |a |capsule |but |was |prescribed |as |an |oral
|solution.
Correct Answers
One |month |prior |to |the |anticipated |approval |date |for |your |product, |the |marketing |application |
that |you |submitted |to |a |major |regulatory |authority |has |become |the |subject |of |an |advisory |
committee |meeting |of |experts |convened |by |the |regulatory |authority. |The |advisory |committee |
members |unanimously |vote |not |to |approve |your |product |because |of |a |safety |concern. |Two |
days |after |the |advisory |committee |meeting, |the |regulatory |authority |requests |additional |
information |to |support |the |safety |of |your |product. |Assuming |you |have |no |additional |data |to |
provide, |which |of |the |following |would |be |your |MOST |appropriate |response |to |the |regulatory |
authority's |request?
See |next |card
1. |"Given |the |advisory |committee's |unanimous |decision, |we |know |that |the |product |will |not |be
|approved, |and |additional |data |will |not |make |any |difference.
2. |"We |have |no |additional |information |to |provide |at |this |time, |but |we |can |perform |an |
additional |analysis |for |a |specific |safety |concern, |if |necessary."
3. |"We |disagree |with |the |advisory |committee's |decision |because |the |committee |neglected |the
|thorough |safety |analysis |that |we |provided."
4. |"We |have |no |additional |information |to |provide |at |this |time |because |we |have |already |
provided |everything |needed |to |support |our |product's |approval."
2. |We |have |no |additional |information |to |provide |at |this |time, |but |we |can |perform |an |
additional |analysis |for |a |specific |safety |concern, |if |necessary
Which |of |the |following |responsibilities |is |specifically |assigned |to |the |Qualified |Person |(QP) |
during |the |batch |release |process?
1. |The |QP |must |ensure |that |all |manufacturing |processes |are |completed |before |batch |release.
2. |The |QP |is |tasked |with |verifying |that |the |batch |meets |the |specifications |outlined |in |the |
Marketing |Authorization.
3. |The |QP |is |responsible |for |conducting |clinical |trials |for |the |product.
4. |The |QP |must |oversee |the |marketing |strategies |for |the |product.
2. |The |QP |is |tasked |with |verifying |that |the |batch |meets |the |specifications |outlined |in |the |
Marketing |Authorization
What |is |the |required |duration |of |continuous |administration |in |months |that |necessitates |the |
evaluation |of |carcinogenic |potential |for |pharmaceutical |products?
,1. |3 |moths
2. |6 |months
3. |12 |months
4. |24 |months
2. |6 |months
A |sponsor |is |planning |to |initiate |a |pivotal |clinical |study |for |a |drug-lead |combination |product |
(e.g. |prefilled |syringe, |autoinjector, |etc.). |For |the |device |constituent |of |the |combination |
product, |what's |the |FDA |minimum |regulatory |requirement |that |must |be |met |prior |to |
introducing |the |combination |product |into |the |clinical |study?
1. |Meet |combination |product |cGMP |requirements
2. |Meet |the |usability |human |factors |requirement.
3. |Meet |the |design |controls |requirement |according |to |21 |CFR |part |820.30, |unless |the |device |
constituent |is |exempt |from |design |controls |requirements.
4. |Meet |the |EU |MDR |General |Safety |and |Performance
3. |Meet |the |design |controls |requirement |according |to |21 |CFR |Part |820.30, |unless |the |device |
constituent |is |exempt |from |design |controls |requirements.
Which |of |the |following |is |false |regarding |FDA |expedited |programs?
1. |The |level |of |evidence |required |for |Fast |Track |Designation |is |less |than |for |Breakthrough |
Therapy |Designation?
2. |Breakthrough |Therapy |Designation |and |RMAT |Designation |require |evidence |that |the |drug |
may |offer |a |substantial |improvement |relative |to |available |therapies.
3. |RMAT |Designation |should |be |requested |with |the |IND |or |later, |but |no |later |than |the |EOP2 |
meeting.
4. |Fast |Track |Designation, |Breakthrough |Therapy |Designation, |and |RMAT |Designation |may |be |
rescinded |later |in |product |development.
2. |Breakthrough |Therapy |Designation |and |RMAT |Designation |require |evidence |that |the |drug |
may |offer |a |substantial |improvement |relative |to |available |therapies.
You |are |a |manufacturer |in |the |US, |and |you |discover |that |your |company's |top |selling |product |
in |the |last |two |years |has |been |used |off-label. |The |off-label |use |is |estimated |to |be |about |70%, |
and |it |has |been |consistent |since |the |product |was |first |released |to |the |market. |Which |of |the |
following |is |the |MOST |appropriate |next |step?
,1. |file |a |report |to |regulatory |authorities |and |advise |the |marketing |department |to |prevent |
future |off-label |use.
2. |Discuss |with |regulatory |authorities |to |investigate |how |to |have |the |off-label |indication |
approved.
3. |Discuss |the |off-label |use |with |Key |Opinion |leaders |(KOLs) |to |determine |how |many |patients |
would |benefit |from |the |approval |of |the |drug.
5. |No |action |is |required |since |it |is |an |off-label |use. |clinicians |have |the |freedom |to |treat |their |
patients |based |on |what |is |medically |appropriate.
2. |Discuss |with |regulatory |authorities |to |investigate |how |to |have |the |off-label |indication |
approved.
In |the |EU, |which |type |of |documentation |should |NOT |be |included |in |Module |1 |of |a |submitted |
dossier?
1. |SmPC, |Labeling, |and |Package |leaflet.
2. |Environmental |Risk |Assessment.
3. |Quality |overall |summary
4. |Risk |management |plan
3. |Quality |Overall |Summary
To |obtain |approval |for |an |ANDA, |a |company |MUST |meet |which |criterion?
1. |Submit |and |receive |approval |for |an |IND
2. |Demonstrate |safety |and |efficacy |of |the |proposed |generic |drug
3. |Demonstrate |bioequivalence |between |the |innovator |drug |and |the |proposed |generic |drug.
4. |Demonstrate |the |efficacy |of |the |innovator |drug |and |the |proposed |generic.
3. |Demonstrate |bioequivalence |between |the |innovator |drug |and |the |proposed |generic |drug
A |firm |is |preparing |a |501(k), |premarket |notification |to |FDA |for |an |in |vitro |diagnostic |test, |a |
microhematocrit |analyzer |that, |among |other |intended |uses, |can |determine |a |blood |donor's |
hematocrit |prior |to |donation. |The |firm |should |address |the |501(k) |submission |to:
1. |CDER
2. |CBER
3. |CDRH
4. |OCP
3. |CDRH
, During |the |review |of |a |company's |NDA |submission |by |the |FDA, |a |new |guideline |is |released |by |
the |FDA |that |affects |the |labeling |requirements |for |the |product. |What |should |the |regulatory |
professional |do |in |response |to |this |change?
1. |Revise |the |labeling |immediately |and |resubmit |to |the |FDA.
2. |Document |the |change |and |address |it |in |the |next |annual |report.
3. |Ignore |the |guideline |as |the |NDA |is |already |under |review.
4. |Consult |with |the |FDA |to |determine |if |a |supplemental |submission |is |necessary.
4. |Consult |with |the |FDA |to |determine |if |a |supplemental |submission |is |necessary.
A |company |is |developing |an |unapproved |cell |and |gene |therapy |that |is |a |combination |product |
(device-biologic). |What |application |and |to |which |center |should |the |company |submit |its |
application |for |marketing |approval?
1. |Submit |a |Premarket |Notification |application |to |CDRH.
2. |Submit |a |Biologic |License |Application |(BLA) |to |CDER
3. |Submit |a |BLA |to |CBER
4. |Submit |an |Investigational |New |Drug |Application |(IND) |tp |CBER
3. |Submit |a |Biologic |License |Application |to |CBER
Which |of |the |following |labeling |elements |is |NOT |required |for |all |over-the-counter |drugs |in |the
|U.S.?
1. |Name |and |place |of |business |of |manufacturer, |packer, |or |distributor?
2. |Net |quantity |of |contents.
3. |Statement |of |ingredients
4. |Pregnancy/breast-feeding |warning.
1. |Name |and |place |of |business |of |manufacturer, |packer, |or |distributor?
Which |of |the |following |is |not |classified |as |an |"Off-label" |use:
1. |A |patient |is |prescribed |an |approved |drug |that |was |deemed |safe |and |effective |for |a |different
|disease |indication.
2. |A |patient |is |prescribed |an |approved |drug |at |a |different |dosage |other |than |the |approved |
label.
3. |A |patient |is |prescribed |a |drug |that |was |approved |as |a |capsule |but |was |prescribed |as |an |oral
|solution.
