Literature DB >> 26236138

Brand and Generics Companies Unite to Pressure FDA: They Want the Agency to Drop Its Safety-Label Plan and Adopt Their Alternative.

Stephen Barlas.   

Abstract

Fear of lawsuits and customer confusion have greeted a Food and Drug Administration plan to let generic drug companies change labels quickly, without prior agency approval, when they learn of adverse effects once the generic reaches the market.

Year:  2015        PMID: 26236138      PMCID: PMC4517532     

Source DB:  PubMed          Journal:  P T        ISSN: 1052-1372


  1 in total

1.  Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule.

Authors: 
Journal:  Fed Regist       Date:  2008-08-22
  1 in total

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