RAPS RAC (DRUG) PRACTICE TEST 103
QUESTIONS WITH ACTUAL SOLUTIONS!!
World Health Organization
Activities Guidelines
, European Medicines Agency International Classification of
Terminology Diseases
Don't know?
2 of 103
Term
A company is developing a new chemical entity. As part of the
preclinical investigations, which of the following battery of toxicity
tests cannot be waived and MUST be completed?
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Teratogenicity Mutagenicity
Carcinogenicity Genotoxicity
Don't know?
3 of 103
Term
On Monday, commercial stability batch testing for an approved drug
produced out-ofspecification results. No assignable cause had been
identified as of Wednesday. What is the best action for the
regulatory professional to take?
,Give this one a try later!
Submit a New Drug Application to
Issue a Field Alert.
CDER.
Submit a Biologic License Ask for a Consultation with the
Application to CBER. Regulatory Agency.
Don't know?
4 of 103
Term
A manufacturer submits a Type IA variation application for a product
authorised through the Mutual Recognition Procedure. Which of the
following courses of action could happen?
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Within 15 days, the Reference Within 90 days, the Reference
Member State rejects the variation Member State requests additional
IA without review. data for the variation IA.
Within 30 days, the Reference
Within 60 days, the Reference
Member State acknowledges
Member State conducts a full
it accepts or rejects the
review of the variation IA.
variation IA.
Don't know?
, 5 of 103
Term
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 a blood donor's hematocrit prior to
donation. The firm should address the 510(k) submission to:
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CDRH CDER
CTP CBER
Don't know?
6 of 103
Term
A regulatory professional is negotiating with the FDA on a product's
final labeling. The company's management is adamant about
including a claim in the labeling, while the FDA is proposing a more
restrictive claim. What is the regulatory professional's BEST course of
action?
Give this one a try later!
QUESTIONS WITH ACTUAL SOLUTIONS!!
World Health Organization
Activities Guidelines
, European Medicines Agency International Classification of
Terminology Diseases
Don't know?
2 of 103
Term
A company is developing a new chemical entity. As part of the
preclinical investigations, which of the following battery of toxicity
tests cannot be waived and MUST be completed?
Give this one a try later!
Teratogenicity Mutagenicity
Carcinogenicity Genotoxicity
Don't know?
3 of 103
Term
On Monday, commercial stability batch testing for an approved drug
produced out-ofspecification results. No assignable cause had been
identified as of Wednesday. What is the best action for the
regulatory professional to take?
,Give this one a try later!
Submit a New Drug Application to
Issue a Field Alert.
CDER.
Submit a Biologic License Ask for a Consultation with the
Application to CBER. Regulatory Agency.
Don't know?
4 of 103
Term
A manufacturer submits a Type IA variation application for a product
authorised through the Mutual Recognition Procedure. Which of the
following courses of action could happen?
Give this one a try later!
Within 15 days, the Reference Within 90 days, the Reference
Member State rejects the variation Member State requests additional
IA without review. data for the variation IA.
Within 30 days, the Reference
Within 60 days, the Reference
Member State acknowledges
Member State conducts a full
it accepts or rejects the
review of the variation IA.
variation IA.
Don't know?
, 5 of 103
Term
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 a blood donor's hematocrit prior to
donation. The firm should address the 510(k) submission to:
Give this one a try later!
CDRH CDER
CTP CBER
Don't know?
6 of 103
Term
A regulatory professional is negotiating with the FDA on a product's
final labeling. The company's management is adamant about
including a claim in the labeling, while the FDA is proposing a more
restrictive claim. What is the regulatory professional's BEST course of
action?
Give this one a try later!
