hmohamed-
used for serious/life-threatening disease, no comparable alt tx, drug is under investigation for the disease, sponsor is pursuing approval, evidence of safety/efficacy, patients won't be exposed to significant risk
What are the conditions for an Investigational drug to be used widespread before approval? (6)
-
physician determines no alt tx/risk from drug isn't worse than disease, FDA determines there is sufficient evidence of safety/efficacy, sponsor submits a protocol to FDA
What are the conditions for Individual patient access to Investigational drugs? (3)
-
authorizes the FDA to allow for the use of an unapproved product
What does an EUA do?
-
all safety data from phase 1/2 studies, phase 3 data w/median follow-up of >=2 months after vaccine regimen
What must be submitted by the sponsor in order for an EUA to be used? (2)
-
bioequivalence, acceptable manufacturing methods/controls
What must be demonstrated in order to be approved for an Abbreviated
New Drug Application (ANDA)? (2)
-
when a drug company wants to make small changes to the drug
What is the Supplemental New Drug Application (SNDA) process for?
-
new chemical entity; new therapeutic indication
A Type 1 chemical is a _________, while a Type 6 is classified as _______.
-
a
Drugs that represent a major therapeutic gain and are given priority review.
a) Type P
b) Type S
-
false
NDC numbers are federally required to appear on prescription labels. T/F?
-
current good manufacturing practices (CGMP)
- a set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product
-
b
How often does the FDA inspect manufacturers for compliance with CGMP?
a) every year
b) every 2 years
c) every 3 years
d) every 5 years
-
a
Which refers to the composition or contamination of the drug?
a) adulteration
b) misbranding
-
a
Which product recall indicates that the product can cause serious AE's or death?
a) Class I
b) Class II
c) Class III
-
b
Which product recall indicates that the product can cause
temporary/medically reversible AE's?
a) Class I
b) Class II
c) Class III
-
c
Which product recall is unlikely to cause adverse health consequences?
a) Class I
b) Class II
c) Class III
-
drug package, package insert, PPI, medguide
What are the components of a drug label? (4)
-
NOT; mandated/reviewed
The sheet printed out at the pharmacy is ______ considered labeling;
it is NOT ________ by the FDA.
-
d
Package inserts are designed for the _______.
a) patient/customer
b) caregivers
c) scientific investigators
d) HC professionals
-
b
Which is the 1st set of numbers on the NDC?
a) product code
b) manufacturer code
c) package code
-
a
Which is the 2nd set of numbers on the NDC?
a) product code
b) manufacturer code
c) package code
-
c
Which is the 3rd set of numbers on the NDC?
a) product code
b) manufacturer code
c) package code
