Literature DB >> 22876212

FDA Readies New Guidance and User Fee Program for Biosimilars: Drug interchangeability and user fees are contentious issues the FDA must resolve. Is the FDA up to the task?

Stephen Barlas.   

Abstract

Year:  2012        PMID： 22876212      PMCID： PMC3411228     

Source DB:  PubMed          Journal:  Biotechnol Healthc        ISSN： 1554-169X


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  3 in total

1.  Evaluation of Biosimilars for Formulary Inclusion: Factors for Consideration by P&T Committees.

Authors:  C Lee Ventola
Journal:  P T       Date:  2015-10

2.  Biosimilars: part 2: potential concerns and challenges for p&t committees.

Authors:  C Lee Ventola
Journal:  P T       Date:  2013-06

3.  Biosimilars: part 1: proposed regulatory criteria for FDA approval.

Authors:  C Lee Ventola
Journal:  P T       Date:  2013-05
  3 in total

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