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pht 101 c1p5

chapter 1 part 5

QuestionAnswer
Patients typically separated into 2 groups
Experimental group receives drug to be tested
Control group receives a standard treatment for the illness or placebo
In the Double blind study trial participants nor study staff know whether a particular participant is in which group
In the Double blind study is the Best way to determine what a new drug does
There are Four Phases of Clinical Trials
Phase I is studied in 20-100 healthy people
Phase II is studied in patients that have the condition it is intended to treat
Phase III is compared to commonly used treatments
Phase IV is the continuation of testing after approval from the market
The FDA approval process took 7 to 10 years
The FDA has made urgently needed drugs available sooner
The Prescription User Fee Act of 1992 shortened the FDA’s review process for new drugs
The PUF Act was on standard applications within 10 months
The PUF Act was on priority applications within 6 months
The FDA considers a new drug safe enough to be approved when the benefits outweigh the risk
FDA approved drugs are not tested on pregnant women
Based on all available information, drugs are grouped into safety categories for use during pregnancy
The FDA has 5 Pregnancy Categories
Category A is no risk
Category B is risk can’t be ruled out
Category C is caution advised
Category D is definite risk
Category X is don’t use
The Office of Compliance is a branch of the FDA that oversees drug manufacturing process
The Office of Compliance ensures that manufacturers follow good manufacturing practices in FDA regulations
Professionals and consumers can report serious adverse reactions to MedWatch, FDA’s Medical Products Reporting Program
If drug poses a health risk, FDA will remove it from the market even though it has already been approved
Created by: moekah
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