RAC Prep Drugs Exam Questions and Answers with Verified
Solutions | Latest 2026 Update
An article intended for use in the diagnosis, cure mitigation treatment or prevention
of disease in man -
Q: drug
-New use of a drug substance or component (active ingredient, excipient, carrier,
coating).
-New use of a combination of approved drugs
-Change in proportion of ingredients in a combination drug
-New intended use of a drug
-Change in dosage, method or duration of administration or application
Answer:
new drug
Central, active part of a molecule or ion responsible for the drug's physiological or
pharmacological action.
Q: -excludes those appended portions of the molecule that cause the drug to be
an ester, salt (including a salt with hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex, chelate, or clathrate) of the
molecule
Answer:
active moiety
Q: A drug that contains no active moiety that has been approved by the FDA in
any other application submitted under section 505(b)
Answer:
new chemical entity (NCE)
Q: Product that has not been previously available for therapeutic use in humans
and is destined to be made available as a prescription-only medicine
Answer:
New molecular entity (NME)
drugs for a disease or condition that affect <200K people in US
-FDA will provide formal protocol assistance if requested
,-Grants are available
Q: - no fee
Answer:
Orphan drug
Q: Sponsors who submit a marketing application for a rare pediatric disease can
be eligible for a Priority Review Voucher for any subsequent application
Answer:
Rare pediatric disease voucher
Shall include:
-drug development progress
-description of upcoming investigational plan
Q: -changes that may affect orphan status
Answer:
Orphan drug annual report
Began with FDAMA 1997 For new drugs that:
-Show superior effectiveness, effect on serious outcomes or improved effect on
serious outcomes
-Avoid serious side effects of an available therapy
-Improve the diagnosis of a serious condition where early diagnosis results in an
improved outcome
-Decrease a clinical significant toxicity of an available therapy that is common and
causes discontinuation of treatment
-Can address emerging or anticipated public health need
-More frequent meetings with FDA to discuss the drug's development plan and
ensure collection of appropriate data needed to support drug approval
-More frequent written communication from FDA about such things as the design
of the proposed clinical trials and use of biomarkers
-May be requested at any time during development (including @ IND submission)
-FDA will provide response in 60 days (designation or non-designation letter)
Q: -Eligible for accelerated app
, Answer:
Fast track designation
Began with FDASIA 2012 For new drugs that:
-An effect on an established surrogate endpoint
-An effect on a surrogate endpoint or intermediate clinical endpoint considered
reasonably likely to predict a clinical benefit (i.e., the accelerated approval
standard)
-An effect on a pharmacodynamic biomarker(s) that does not meet criteria for an
acceptable surrogate endpoint, but strongly suggests the potential for a clinically
meaningful effect on the underlying disease
-A significantly improved safety profile compared to available therapy (e.g., less
dose-limiting toxicity for an oncology agent), with evidence of similar efficacy
Adds to benefits of Fast Track
-Intensive guidance on an efficient drug development program, beginning as early
as Phase 1
-Organizational commitment involving senior managers
-Submit concurrent to IND or no later than EoP2 meeting
Q: -FDA will respond within 60 days
Answer:
Breakthrough designation
For drugs that:
-allows approval based on surrogate or an intermediate clinical endpoint
-reduces clinical trial timeline
-disease must be serious or life-threatening
Q: -treatment must be better than existing treatments
Answer:
Accelerated approval
For drugs that:
-provide major advances in treatment or provide treatment where no therapy exists,
-eliminates or reduces treatment-limiting reaction,
-evidence of enhanced patient compliance,
-evidence of safety and compliance in a new subpopulation such as children
Solutions | Latest 2026 Update
An article intended for use in the diagnosis, cure mitigation treatment or prevention
of disease in man -
Q: drug
-New use of a drug substance or component (active ingredient, excipient, carrier,
coating).
-New use of a combination of approved drugs
-Change in proportion of ingredients in a combination drug
-New intended use of a drug
-Change in dosage, method or duration of administration or application
Answer:
new drug
Central, active part of a molecule or ion responsible for the drug's physiological or
pharmacological action.
Q: -excludes those appended portions of the molecule that cause the drug to be
an ester, salt (including a salt with hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex, chelate, or clathrate) of the
molecule
Answer:
active moiety
Q: A drug that contains no active moiety that has been approved by the FDA in
any other application submitted under section 505(b)
Answer:
new chemical entity (NCE)
Q: Product that has not been previously available for therapeutic use in humans
and is destined to be made available as a prescription-only medicine
Answer:
New molecular entity (NME)
drugs for a disease or condition that affect <200K people in US
-FDA will provide formal protocol assistance if requested
,-Grants are available
Q: - no fee
Answer:
Orphan drug
Q: Sponsors who submit a marketing application for a rare pediatric disease can
be eligible for a Priority Review Voucher for any subsequent application
Answer:
Rare pediatric disease voucher
Shall include:
-drug development progress
-description of upcoming investigational plan
Q: -changes that may affect orphan status
Answer:
Orphan drug annual report
Began with FDAMA 1997 For new drugs that:
-Show superior effectiveness, effect on serious outcomes or improved effect on
serious outcomes
-Avoid serious side effects of an available therapy
-Improve the diagnosis of a serious condition where early diagnosis results in an
improved outcome
-Decrease a clinical significant toxicity of an available therapy that is common and
causes discontinuation of treatment
-Can address emerging or anticipated public health need
-More frequent meetings with FDA to discuss the drug's development plan and
ensure collection of appropriate data needed to support drug approval
-More frequent written communication from FDA about such things as the design
of the proposed clinical trials and use of biomarkers
-May be requested at any time during development (including @ IND submission)
-FDA will provide response in 60 days (designation or non-designation letter)
Q: -Eligible for accelerated app
, Answer:
Fast track designation
Began with FDASIA 2012 For new drugs that:
-An effect on an established surrogate endpoint
-An effect on a surrogate endpoint or intermediate clinical endpoint considered
reasonably likely to predict a clinical benefit (i.e., the accelerated approval
standard)
-An effect on a pharmacodynamic biomarker(s) that does not meet criteria for an
acceptable surrogate endpoint, but strongly suggests the potential for a clinically
meaningful effect on the underlying disease
-A significantly improved safety profile compared to available therapy (e.g., less
dose-limiting toxicity for an oncology agent), with evidence of similar efficacy
Adds to benefits of Fast Track
-Intensive guidance on an efficient drug development program, beginning as early
as Phase 1
-Organizational commitment involving senior managers
-Submit concurrent to IND or no later than EoP2 meeting
Q: -FDA will respond within 60 days
Answer:
Breakthrough designation
For drugs that:
-allows approval based on surrogate or an intermediate clinical endpoint
-reduces clinical trial timeline
-disease must be serious or life-threatening
Q: -treatment must be better than existing treatments
Answer:
Accelerated approval
For drugs that:
-provide major advances in treatment or provide treatment where no therapy exists,
-eliminates or reduces treatment-limiting reaction,
-evidence of enhanced patient compliance,
-evidence of safety and compliance in a new subpopulation such as children
