Nevada MPJE COMPREHENSIVE QUESTIONS
WITH MULTIPLE CHOICES |VERIFIED &
REVISED ANSWERS (NEW) 2026
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Terms in this set (182)
Laws vs. Regulations laws - enacted through a federal or state
legislative process
regulations - (or rules) provide specific details to
help implement the law, and are issued by state
regulatory agencies (e.g. state board of
pharmacy)
FDA Drug Approval Process 1) pre-clinical testing (animals)
2) manufacturer files an investigational new drug
(INDA) application with the FDA
3) INDA approval --> begin Phase 1 study, Phase
2, then Phase 3
4) file a new drug application (NDA) or biologic
license application (BLA) to FDA
5) If drug approved, phase 4 study (post-
marketing surveillance)
Phase 1 study assesses safety and adverse effects, as well as PK
and PD profile. Small number of healthy subjects
(~20-80)
Phase 2 study focuses on safety and efficacy. subjects have the
indicated condition (~35-100). dose ranging
analyzed to determine optimum dose
,Phase 3 study determines efficacy for treating the condition
compared to a placebo or gold-standard
treatment. larger number of patients (~300-3000)
Phase 4 study (post-marketing surveillance). conducted after
the drug is approved and released for use. can
be requested by the FDA or initiated by the
manufacturer. can be used to monitor special
populations or long-term effects of drug
exposure
FDA Drug Approval Time - the NDA or BLA is evaluated by the FDA
through the Center for Drug Evaluation and
Research (CDER)
- CDER is expected to review 90% of applications
for standard drugs within 10 months of receiving
the application, and within 6 months for priority
drugs
Prescription Drug User Fee Act FDA was given authority to collect fees from the
(PDUFA) "user" (drug manufacturer) in order for the FDA to
review the new drug applications and
supplements. the funds are used to hire reviewers
to help expedite the review process
OTC Drug Approval Process either approved thru NDA process used for Rx's
or can be approved thru the simpler OTC drug
monograph process ("three-phase public
rulemaking process")
Generic Drug Approval Process must complete an Abbreviated New Drug
Application (ANDA). does not require pre-clinical
animal studies and clinical studies w/ human
subjects. requires a simpler bioequivalency
analysis between the generic and the Reference
Listed Drug
, Drug Advertising (Rx and OTC) Rx - regulated primarily by the FDA
OTC - regulated primarily by the Federal Trade
Commission (FTC)
- Direct-to-consumer advertising is not federally
legislated and FDA pre-approval is not required
Sherman Antitrust Act of 1890 attempted to outlaw monopolies that blocked
competition by nefarious methods, such as price-
fixing, deceptive marketing practices, and
excluding competition from markets
Pure Food and Drug Act of 1906 -the first legislation in the U.S. that offered
(the Wiley Act) protection to consumers from drug misuse.
-mandated accurate product labeling
-ingredients used in drugs meet the standards of
strength, quality, and purity in the USP and NF
-required that the food or drug label could not
be false or misleading. presence and amount
dangerous ingredients must be listed
-no adulterated or misbranded drugs could be
sent thru interstate commerce
Adulteration vs. Misbranding Adulteration- involves the drug itself (quality)
Misbranding- incorrect or missing info on the
container of labeling
WITH MULTIPLE CHOICES |VERIFIED &
REVISED ANSWERS (NEW) 2026
Save
Terms in this set (182)
Laws vs. Regulations laws - enacted through a federal or state
legislative process
regulations - (or rules) provide specific details to
help implement the law, and are issued by state
regulatory agencies (e.g. state board of
pharmacy)
FDA Drug Approval Process 1) pre-clinical testing (animals)
2) manufacturer files an investigational new drug
(INDA) application with the FDA
3) INDA approval --> begin Phase 1 study, Phase
2, then Phase 3
4) file a new drug application (NDA) or biologic
license application (BLA) to FDA
5) If drug approved, phase 4 study (post-
marketing surveillance)
Phase 1 study assesses safety and adverse effects, as well as PK
and PD profile. Small number of healthy subjects
(~20-80)
Phase 2 study focuses on safety and efficacy. subjects have the
indicated condition (~35-100). dose ranging
analyzed to determine optimum dose
,Phase 3 study determines efficacy for treating the condition
compared to a placebo or gold-standard
treatment. larger number of patients (~300-3000)
Phase 4 study (post-marketing surveillance). conducted after
the drug is approved and released for use. can
be requested by the FDA or initiated by the
manufacturer. can be used to monitor special
populations or long-term effects of drug
exposure
FDA Drug Approval Time - the NDA or BLA is evaluated by the FDA
through the Center for Drug Evaluation and
Research (CDER)
- CDER is expected to review 90% of applications
for standard drugs within 10 months of receiving
the application, and within 6 months for priority
drugs
Prescription Drug User Fee Act FDA was given authority to collect fees from the
(PDUFA) "user" (drug manufacturer) in order for the FDA to
review the new drug applications and
supplements. the funds are used to hire reviewers
to help expedite the review process
OTC Drug Approval Process either approved thru NDA process used for Rx's
or can be approved thru the simpler OTC drug
monograph process ("three-phase public
rulemaking process")
Generic Drug Approval Process must complete an Abbreviated New Drug
Application (ANDA). does not require pre-clinical
animal studies and clinical studies w/ human
subjects. requires a simpler bioequivalency
analysis between the generic and the Reference
Listed Drug
, Drug Advertising (Rx and OTC) Rx - regulated primarily by the FDA
OTC - regulated primarily by the Federal Trade
Commission (FTC)
- Direct-to-consumer advertising is not federally
legislated and FDA pre-approval is not required
Sherman Antitrust Act of 1890 attempted to outlaw monopolies that blocked
competition by nefarious methods, such as price-
fixing, deceptive marketing practices, and
excluding competition from markets
Pure Food and Drug Act of 1906 -the first legislation in the U.S. that offered
(the Wiley Act) protection to consumers from drug misuse.
-mandated accurate product labeling
-ingredients used in drugs meet the standards of
strength, quality, and purity in the USP and NF
-required that the food or drug label could not
be false or misleading. presence and amount
dangerous ingredients must be listed
-no adulterated or misbranded drugs could be
sent thru interstate commerce
Adulteration vs. Misbranding Adulteration- involves the drug itself (quality)
Misbranding- incorrect or missing info on the
container of labeling
