NEVADA MPJE Questions and Correct Answers | Latest Update
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Course
Nevada MPJE
Institution
Nevada MPJE
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 te...
Best Grades | Must Pass | Latest Update | Correct Answers | 2024/ 2025
NEVADA MPJE Questions and Correct
Answers | Latest Update
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)
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, Best Grades | Must Pass | Latest Update | Correct Answers | 2024/ 2025
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 (PDUFA)
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, Best Grades | Must Pass | Latest Update | Correct Answers | 2024/ 2025
FDA was given authority to collect fees from the "user" (drug
manufacturer) in order for the FDA to review the new drug applications
and supplements. the funds are used to hire revie wers 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
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, Best Grades | Must Pass | Latest Update | Correct Answers | 2024/ 2025
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 Wiley Act)
-the first legislation in the U.S. that offered 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
Food, Drug, and Cosmetic Act of 1938
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