Title: | Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy |
Journal : | JAMA. Journal of the American Medical Association, 316, 22 |
Authors: | Kesselheim AS, Author ; Avorn J |
Material Type: | Article |
Publication Date: | 2016 |
Size: | p 2357 |
General note: |
Erratum in:
Error in Text. [JAMA. 2017] |
Languages: | English |
Keywords : | clinical trials ; controversy ; drug marketing regulation in France ; Duchenne muscular dystrophy ; dystrophin ; eteplirsen ; FDA (Food and drug administration) |
Abstract: |
Comment in:
FDA Approval of Eteplirsen for Muscular Dystrophy. [JAMA. 2017] FDA Approval of Eteplirsen for Muscular Dystrophy. [JAMA. 2017] |
Pubmed / DOI : | DOI : 10.1001/jama.2016.16437 / Pubmed : 27775756 |
Link for e-copy: | http://www.ncbi.nlm.nih.gov/pubmed/27775756 |
See also : |