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LSUS MHA 707: Medicines, Devices, and Technology - Ch. 4 Questions and Answers
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LSUS MHA 707: Medicines, Devices, and Technology - Ch. 4 Questions and Answers
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LSUS MHA 707: Medicines, Devices, andTechnology - Ch. 4 Questions and Answers
12 steps to NDA process - ✔✔1. Preclinical (animal) testing
2. An investigational nda outlines what the new drug proposes for human testing
3. Phase one, 20 to 80 people
4. Phase two, a few dozen to 300 people
5. Phase three, several hundred to 3000 people
6. Pre NDA period, FDA and drug sponsors to meet
7. Submission of NDA asking the FDA to consider the drug
8. FDA has 60 days to decide whether the file can be reviewed
9. If FDA files the NDA a review team is assigned to evaluate the sponsors research
10. The FDA reviews information that goes on the label
11. The FDA inspects the facilities where the drug will be manufactured
12. FDA reviewers approve the application
How does the process differ for biologics subjects? - ✔✔A biologics license application (BLA)
replaces the NDA and emphasis is placed on manufacturing control for products
Operation Warp Speed - ✔✔A public-private partnership aimed at rapidly developing and
making COVID-19 vaccines available
Abbreviated New Drug Application (ANDA) - ✔✔Allows the competitor to produce and
market a drug equivalent to an approved brand name drug- commonly referred to as generic-
without conducting the same clinical trials
Post marketing surveillance programs of the FDA - ✔✔used to identify adverse events that
did not appear during the drug approval process
, How long can the process of bringing a new drug to the market take? - ✔✔Up to 15 years
"Behind the counter" drugs - ✔✔Drugs that do not require prescription but must be
dispensed by a pharmacist
Intellectual property protections - ✔✔Legal safeguards critical for attracting investment in
the development of new drugs
Generics and Biosimilars - ✔✔Equivalent drugs developed and sold by competitors after the
expiration of patents for original medications
Total Spending on OTC drugs - ✔✔The total expenditure on over-the-counter drugs, which
was $34.6 billion in 2017
Restricted formularies with tiered copays and or co-insurance are... - ✔✔An attempt to
incentivize patients toward lower cost solutions, but can generate a lot of conflict
Pharmacy benefit managers (PBM) - ✔✔Insurance plans used to help them manage their
prescription drug benefits, drug manufacturers, and retail pharmacies
Pricing of drugs - ✔✔The determination of drug prices, including the shift to generics when
available and limited controls on formulary and pricing for specialty drugs
Amount spent on prescription drugs in retail settings - ✔✔$333 billion
Amount spent on prescription drugs in non retail settings - ✔✔$148 billion
Medical Devices - ✔✔Items used in the diagnosis, cure, mitigation, treatment, or prevention
of diseases
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