Abstract
Get full access to this article
View all access options for this article.
References
1.Guidance for industry: bioequivalence recommendations for specific products. http://www.fda.gov/Drugs/GuidanceComplianceRegulatorylnformation/Guidances/default.htm. Accessed May 20, 2012.
2.Classifying significant postmarketing drug safety issues. Draft guidance. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295211.pdf. Accessed May 20, 2012.
3.FDA Statement regarding azithromycin (Zithromax ) and the risk of cardiovascular death. http://www.fda.gov/Drugs/DrugSafety/ucm304372.htm. Accessed May 20, 2012.
4.Trastuzumab (labeling change). http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm231970.htm. Accessed May 20, 2012.