Literature DB >> 24883007

FDA devotes new resources to upgrading generic drug safety: but in some instances, the industry is pushing back.

Stephen Barlas.   

Abstract

The Food and Drug Administration, concerned about the quality of the generic drugs that represent 84 percent of U.S. prescriptions, is looking more closely at foreign manufacturing plants and weighing other changes in the generic approval process.

Year:  2014        PMID: 24883007      PMCID: PMC4029123     

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


  2 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

2.  Comparing the biological impact of glatiramer acetate with the biological impact of a generic.

Authors:  Fadi Towfic; Jason M Funt; Kevin D Fowler; Shlomo Bakshi; Eran Blaugrund; Maxim N Artyomov; Michael R Hayden; David Ladkani; Rivka Schwartz; Benjamin Zeskind
Journal:  PLoS One       Date:  2014-01-08       Impact factor: 3.240

  2 in total

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