MHA 707 B Exams contains Exams Questions with
verified answers and complete study solutions | Latest
2026/2027 - (Everything you need to pass MHA 707 is
here)
FDA (Food and Drug Administration) - Answer-:;Products intended to cure, treat,
mitigate, diagnose, or prevent disease in humans or otherwise affect the
structure or function of the human body through chemical action in and/or
metabolized by the human body are considered human drugs or biological
products.
Biological Products - Answer-:;complex mixtures of "big molecule drugs"
produced through biotechnology in a living system, such as a microorganism,
plant cell, or animal cell are not easily identified or characterized.
Biologics Characteristics - Answer-:;•Due to their complex nature, it is challenging
to ensure the product remains consistent, and so the production process
becomes critical ("the product is the process")
•considered a "specialty" drug
•In 2018, biologic market est. at $125 B (up 50% from 2014)
•represent the cutting edge of biomedical research
17% of all drug approvals
•is 3 of the top selling medicines in 2017
,What are the two classes of FDA drugs? - Answer-:;Conventional" or "small
molecule" drugs typically contain an active pharmaceutical ingredient
Speciality Drug Criteria - Answer-:;•Available in very limited supply
•Require special handling (e.g., constant temperature regulation or biohazard or
similar toxicity)
•Have a very high price tag
•Includes Orphan Drugs and Biologics
• 4 of the top 5 med were specialty, net spending is 46.5%
GRASE (general recognized as safe and effective) Criteria - Answer-:;which
requires published research
supporting safe unsupervised use of the product
OTC drugs
DEA Drug Schedules - Answer-:;•Schedule I: no accepted medical use and a high
potential for abuse and therefore may not be prescribed or dispensed
•Schedule II-V: varying controls on their manufacture, distribution, and sales
•Unscheduled: no DEA restrictions
•The FDA does not proactively control vitamins and supplements
Americans spent ~$34 B in 2019
, New Drug Application (NDA) - Answer-:;process that includes animal testing,
progressively larger human trials, review of the drug's labeling, and an inspection
of the facilities where the drug would be manufactured
Rule of GRASE - Answer-:;Drugs must be made available OTC if consumers can use
it safely and effectively without professional guidance per package labelling
Cost and Speciality Drugs - Answer-:;4 of the top 5 medicines by nondiscounted
spending were specialty drugs and specialty share of net spending on drugs rose
from 24.7% in 2008 to 46.5%
Orphan Disease - Answer-:;Diseases that occur in less than 200,000 people in the
U.S.
Therefore, drugs for these diseases wouldn't be economically feasible to
develop unless subsidized
- Includes most "biologicals"
Orphan Drug Act of 1983 - Answer-:;grants special tax treatment and sometimes
offers
federal grant money to fund research
Orphan drugs for cancer generate the largest profits
Development of new drugs - Answer-:;Patents could last up to 20 years from date
of filing
It can cost millions to billions of dollars
Could take up to 15 years to be FDA approved
verified answers and complete study solutions | Latest
2026/2027 - (Everything you need to pass MHA 707 is
here)
FDA (Food and Drug Administration) - Answer-:;Products intended to cure, treat,
mitigate, diagnose, or prevent disease in humans or otherwise affect the
structure or function of the human body through chemical action in and/or
metabolized by the human body are considered human drugs or biological
products.
Biological Products - Answer-:;complex mixtures of "big molecule drugs"
produced through biotechnology in a living system, such as a microorganism,
plant cell, or animal cell are not easily identified or characterized.
Biologics Characteristics - Answer-:;•Due to their complex nature, it is challenging
to ensure the product remains consistent, and so the production process
becomes critical ("the product is the process")
•considered a "specialty" drug
•In 2018, biologic market est. at $125 B (up 50% from 2014)
•represent the cutting edge of biomedical research
17% of all drug approvals
•is 3 of the top selling medicines in 2017
,What are the two classes of FDA drugs? - Answer-:;Conventional" or "small
molecule" drugs typically contain an active pharmaceutical ingredient
Speciality Drug Criteria - Answer-:;•Available in very limited supply
•Require special handling (e.g., constant temperature regulation or biohazard or
similar toxicity)
•Have a very high price tag
•Includes Orphan Drugs and Biologics
• 4 of the top 5 med were specialty, net spending is 46.5%
GRASE (general recognized as safe and effective) Criteria - Answer-:;which
requires published research
supporting safe unsupervised use of the product
OTC drugs
DEA Drug Schedules - Answer-:;•Schedule I: no accepted medical use and a high
potential for abuse and therefore may not be prescribed or dispensed
•Schedule II-V: varying controls on their manufacture, distribution, and sales
•Unscheduled: no DEA restrictions
•The FDA does not proactively control vitamins and supplements
Americans spent ~$34 B in 2019
, New Drug Application (NDA) - Answer-:;process that includes animal testing,
progressively larger human trials, review of the drug's labeling, and an inspection
of the facilities where the drug would be manufactured
Rule of GRASE - Answer-:;Drugs must be made available OTC if consumers can use
it safely and effectively without professional guidance per package labelling
Cost and Speciality Drugs - Answer-:;4 of the top 5 medicines by nondiscounted
spending were specialty drugs and specialty share of net spending on drugs rose
from 24.7% in 2008 to 46.5%
Orphan Disease - Answer-:;Diseases that occur in less than 200,000 people in the
U.S.
Therefore, drugs for these diseases wouldn't be economically feasible to
develop unless subsidized
- Includes most "biologicals"
Orphan Drug Act of 1983 - Answer-:;grants special tax treatment and sometimes
offers
federal grant money to fund research
Orphan drugs for cancer generate the largest profits
Development of new drugs - Answer-:;Patents could last up to 20 years from date
of filing
It can cost millions to billions of dollars
Could take up to 15 years to be FDA approved
