Acts
Clinical Trials
Drug Approval Process
DEA Schedules
Magically Miscellaneous
100
This act was created after 107 people were poisoned by an untested sulfanilamide concoction.
What is the Food, Drug, and Cosmetic Act of 1938.
100
The first phase of clinical trials is mainly used to test THIS.
What is Safety.
100
This act extends a patent up to five years to compensate for lost time in research before going to market.
What is the Hatch-Waxman Act.
100
Tylenol with Codeine
What is Schedule III.
100
To get Plan B as an OTC drug, you have to be____.
What is 17 years old.
200
This act distinguishes between Legend (or prescription) drugs and over-the-counter (OTC) drugs.
What is the Durham-Humphrey Amendment.
200
Only about 25% of drugs tested in this phase ever reach the market.
What is Phase I.
200
While a drug is undr this, it cannot be be marketed by other companies.
What is patent.
200
Lyrica
What is Schedule V.
200
The Controlled Sustances Act was enacted in this year.
What is 1970
300
This amendment states that once a drug is proven safe and effective, the manufacturer may submit an NDA seeking approval to market the product.
What is the Kefauver-Harris Amendment.
300
Phase III of clinical trials is the first phase to test this.
What is Dosage.
300
In this type of trial, the patient or the doctor who is treating the patient which arm of the study a particular patient is on.
What is Blind.
300
Marijuana
What is Schedule I.
300
This type of recall can cause serious adverse effects or death.
What is Class I.
400
This act was passed to prevent accidental childhood poisonings from prescription and nonprescription products.
What is the Poison Prevention Packaging Act.
400
This phase begins after the drug is approved.
What is Phase IV.
400
This type of drug has a limitation of 3.6 grams per day.
What is Pseudoephedrine or Ephedrine.
400
Xanax
What is Schedule IV.
400
What does JACHO stand for?
What is Joint Commission on Accreditation of Health Care Organizations.
500
This act provides incentives to promote research of drugs required for the treatment of rare diseases.
What is the Orphan Drug Act.
500
In this, a goup of patients with similar conditions are randomly given a treatment or placebo to test the efficacy of a drug.
What is a controlled trial.
500
Pseudoephedrine containing products have a limitation of THIS per month.
What is 7.5 grams.
500
Oxycodone
What is Schedule II.
500
The first five digits of an NDC number stand for this.
What is the maniufacturer.
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