Transcript umass medical school meyers primary care institute

Pharmaceutical Development
and Regulation
Name brands, generics
and the FDA
Case
• Your patient is taking Gudaznu
• There is concern because of a news report
issued by the FDA
• The patient wants to talk to you
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
We return to our case…
You anticipate questions about the safety of
Gudaznu
You rarely prescribe the drug, but do have a
few patients taking it
You start to wonder yourself how it could have
been approved by the FDA
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
We return to our case…
You are able to make a convincing
argument to your patient
If the generic medication does not work well,
there are a number of other options available
You feel good that you are able to provide
information which may help your patients’
understanding of their treatment
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE