Question

A) Identify two articles from the published literature that detail FDA recommended changes to a package insert. Indicate the data that led to this decision. B) Identify a package insert from a different pharmaceutical product than atorvastatin. Compare and contrast the sections noting the similarities and dissimilarities amongst the various sections.

Answer 1

A). We can find many articles on FDA recommanded changes to a package insert from the website of FDA itself

alternately you may navigate through the following path to get good articles on it.

1. website of fda>>downloads>>training>>forhealthprofessionals>>ucm090796.pdf

2. go to fda website>>Drugs>>LawsActsandRules>>ucm188665.htm

B).