Lec 4 Drug Approval and Development Flashcards
amendment passed as a result of the thalidomide disaster
a. Sherley Amendment
b. Durham-Humphrey Amendment
c. Kefauver-Harris Amendment
c. Kefauver-Harris Amendment
which of the following is NOT part of the Kefauver-Harris Amendment?
a. medications must demonstrate both safety and efficacy
b. authorized factory inspections
c. transferred jurisdiction of prescription drug advertising from the FTC to the FDA
d. added informed consent and reporting of ADRs for clinical investigations
b. authorized factory inspections
(this is from the Federal Food, Drug, and Cosmetic Act)
any manufacturer for drugs used in the U.S. must be registerd with the FDA and undergo an inspection at least once every ___ years
a. one
b. two
c. three
d. four
b. two
if you don’t comply with cGMP, the product is
a. adulterated
b. misbranded
c. both
d. neither
a. adulterated
if a manufacturer doesn’t register with the FDA, the product is
a. adulterated
b. misbranded
c. both
d. neither
c. both
in law, making drugs falls into what 3 general categories?
- pharmacy or traditional compounding (503a)
- outsourcing facilities (503b)
- manufacturing
compounding according to prescriptions specific to particular patients on an as needed basis.
a. pharmacy or traditional compounding (503a)
b. outsourcing facilities (503b)
c. manufacturing
a. pharmacy or traditional compounding (503a)
manufacturing large batches with or without prescriptions to be sold to facilities for office use only.
a. pharmacy or traditional compounding (503a)
b. outsourcing facilities (503b)
c. manufacturing
b. outsourcing facilities (503b)
mass production of drug products that have been approved by the Food and Drug Administration.
a. pharmacy or traditional compounding (503a)
b. outsourcing facilities (503b)
c. manufacturing
c. manufacturing
meeting the requirements for 503a compounding will exempt the pharmacy from meeting regulations related to: (3 things)
-cGMP
-Misbranding (related to drug labeling)
-New Drug Requirements
which of the following is FALSE about outsourcing facilities?
a. no prescription needed for a specific pt
b. must register, pay annual fees, and be inspected by FDA
c. can compound an already commercially available product
c. can compound an already commercially available product
product labels for outsourcing facilities must contain: (11 things, it’s a lot)
-statement “this is a compounded drug”
-name, address, phone number of outsourcing facility
-lot number or batch number
-established name of the drug
-dosage or strength
-quantity or volume
-beyond use date
-storage and handling instructions
-NDC
-statement “not for resale”
-list of active and inactive ingredients
which laws are applicable to pharmacy compounding (503a)?
a. misbranding
b. cGMP
c. new drug requirements
d. all of the above
e. none of the above
e. none of the above
which laws are applicable to outsourcing facilities (503b)? SELECT ALL THAT APPLY
a. misbranding
b. cGMP
c. new drug requirements
d. all of the above
e. none of the above
a. misbranding (labeling/packaging)
b. cGMP
which laws are applicable to drug manufacturers?
a. misbranding
b. cGMP
c. new drug requirements
d. all of the above
e. none of the above
d. all of the above
Kefauver-Harris amendment: what happened to drugs still on the market that came out BEFORE 1938?
assumed to be safe and effective, “grandfathered” in
Kefauver-Harris amendment: what happened to drugs that came out AFTER 1938?
they are investigated for efficacy, any issues recommended to the FDA (DESI = drug efficacy study implementation)
T or F: for DESI, products must be pulled from the market until a decision is made
F
T or F: some DESI decisions have yet to be made, even today
T
in vivo animal testing
a. preclinical research
b. phase I
c. phase II
d. phase III
e. post-marketing safety monitoring
a. preclinical research
the Investigational New Drug (IND) must contain what 3 things?
-animal pharmacology and toxicology studies
-manufacturing information
-clinical protocols and investigator information
Once the IND is submitted, the sponsor must wait ___ days before initiating any clinical trials to allow the FDA to review the IND for safety and unreasonable risk.
a. 2
b. 5
c. 30
d. 180
c. 30
evaluates safety and dosage of the compound; healthy human volunteers; baseline human PK and PD properties reviewed
a. preclinical research
b. phase I
c. phase II
d. phase III
e. post-marketing safety monitoring
b. phase I
determine the effectiveness of therapy; several hundred human volunteers with the disease
a. preclinical research
b. phase I
c. phase II
d. phase III
e. post-marketing safety monitoring
c. phase II
Goal is to demonstrate efficacy at a higher power, and to expand information around adverse effects; hundreds/thousands of pts in several geographic locations
a. preclinical research
b. phase I
c. phase II
d. phase III
e. post-marketing safety monitoring
d. phase III
new drug application (NDA) must include everything from preclinical data to phase 3 trial data. It also must include: (7 things)
-proposed labeling
-safety updates
-drug abuse information
-pt information
-data from studies outside the U.S.
-institutional review board compliance information
-directions for use
-FDA reviews MedWatch
-routine manufacturer inspections
a. preclinical research
b. phase I
c. phase II
d. phase III
e. post-marketing safety monitoring
e. post-marketing safety monitoring (phase 4)
NDA timeline: how much total time does it take? (range)
3.5-13.5 years
law enacted to encourage the development of drugs for rare disease states
Orphan Drug Act
Hatch-Waxman act purpose
to reduce the requirements for approval of generic prescription drugs
look at Orphan Drug Act (slide 24)
you got it
which of the following is TRUE about the Hatch-Waxman Act?
a. before this act, generics can be approved without impinging on patent
b. after this act, generic companies had to perform own safety and efficacy studies
c. before this act, approval for generics can’t be started until the patent expires
d. before this act, generic companies had to prove bioequivalence and proof of acceptable manufacturing
c. before this act, approval for generics can’t be started until the patent expires
difference between NDA and abbreviated NDA
abbreviated NDA does not need animal or human clinical trial date to establish safety and effectiveness
What term is being described?: demonstration that the rate of absorption of the generic drug is equivalent to that of the innovator drug. Must deliver the same amount of ingredient in the same amount of time
bioequivalence
what document needs to be submitted after preclinical research in the drug development process?
IND (investigational new drug application)
