1. Pharmaceutical Development and Regulation Name brands, generics and the FDA

2. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE 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

3. 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

4. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE 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 We return to our case…