NEVADA MPJE 2026 FULL PRACTICE EXAM
◉ FDA Drug Approval Process Answer: 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 Answer: assesses safety and adverse effects, as well
as PK and PD profile. Small number of healthy subjects (~20-80)
◉ Phase 2 study Answer: focuses on safety and efficacy. subjects
have the indicated condition (~35-100). dose ranging analyzed to
determine optimum dose
◉ Phase 3 study Answer: determines efficacy for treating the
condition compared to a placebo or gold-standard treatment. larger
number of patients (~300-3000)
◉ Phase 4 study Answer: (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 Answer: - 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) Answer: 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 reviewers to help expedite
the review process
◉ OTC Drug Approval Process Answer: 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 Answer: 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) Answer: 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 Answer: 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) Answer: -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 Answer: Adulteration- involves the
drug itself (quality)
, Misbranding- incorrect or missing info on the container of labeling
◉ Food, Drug, and Cosmetic Act of 1938 Answer: -after diethylene
glycol use as a solvent resulted in fatalities
-marked the birth of the modern FDA
-required that the manufacturer prove the safety of the drug before
it could be marketed
-authorized the FDA to conduct manufacturer and distributor
inspections , and established penalties for using misleading labeling
-product claims must be accurate and all ingredients must be listed
on the label so that the public is aware of what they are ingesting
-defined the terms food, drugs, dietary supplements, devices, and
cosmetics
-prohibited adulterated or misbranded drugs in interstate
commerce
- drug products marketed prior to 1938 were exempted or
"grandfathered"
◉ Public Health Service Act of 1944 Answer: defined biological
products. biologics are approved under a biologics license
application (BLA). requires biologic be approved for potency and
safety
◉ Durham-Humphrey Amendment of 1951 Answer: -first time a
clear distinction was made between OTC and Rx drugs.
◉ FDA Drug Approval Process Answer: 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 Answer: assesses safety and adverse effects, as well
as PK and PD profile. Small number of healthy subjects (~20-80)
◉ Phase 2 study Answer: focuses on safety and efficacy. subjects
have the indicated condition (~35-100). dose ranging analyzed to
determine optimum dose
◉ Phase 3 study Answer: determines efficacy for treating the
condition compared to a placebo or gold-standard treatment. larger
number of patients (~300-3000)
◉ Phase 4 study Answer: (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 Answer: - 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) Answer: 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 reviewers to help expedite
the review process
◉ OTC Drug Approval Process Answer: 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 Answer: 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) Answer: 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 Answer: 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) Answer: -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 Answer: Adulteration- involves the
drug itself (quality)
, Misbranding- incorrect or missing info on the container of labeling
◉ Food, Drug, and Cosmetic Act of 1938 Answer: -after diethylene
glycol use as a solvent resulted in fatalities
-marked the birth of the modern FDA
-required that the manufacturer prove the safety of the drug before
it could be marketed
-authorized the FDA to conduct manufacturer and distributor
inspections , and established penalties for using misleading labeling
-product claims must be accurate and all ingredients must be listed
on the label so that the public is aware of what they are ingesting
-defined the terms food, drugs, dietary supplements, devices, and
cosmetics
-prohibited adulterated or misbranded drugs in interstate
commerce
- drug products marketed prior to 1938 were exempted or
"grandfathered"
◉ Public Health Service Act of 1944 Answer: defined biological
products. biologics are approved under a biologics license
application (BLA). requires biologic be approved for potency and
safety
◉ Durham-Humphrey Amendment of 1951 Answer: -first time a
clear distinction was made between OTC and Rx drugs.
