Reference
Generic Pharmaceutical Association. GPhA Overview and Assessment: Food and Drug Administration's Proposed Rule Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Internet Document : [11 pages], Jan 2014. Available from: URL: http://www.gphaonline.org/media/cms/GPhA_Labeling_White_Paper_1.29.14_FINAL.pdf
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* see Reactions 1478 p4; 803095800
** Abbreviated New Drug Application
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GPhA concerned about FDA's proposed labelling changes. Reactions Weekly 1488, 4 (2014). https://doi.org/10.1007/s40278-014-8753-z
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DOI: https://doi.org/10.1007/s40278-014-8753-z