What aspects of antimicrobial trials are unique in terms of patient treatment and rules governing who can participate?
1) – For this week’s writing assignment, you will consider the practice of off-label use. Write a one to two pages essay describing this practice and if you believe that doctors should be engaging in it.
2) Who is labeling for—patients, companies, health workers
3) What regulations govern labeling? How are they applied by the USFDA
4) What aspects of antimicrobial trials are unique in terms of patient treatment and rules governing who can participate? 5) How is a clinical trial for a medical device similar to or different from a clinical trial for a drug?
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