Literature DB >> 22948694

The safety risks of innovation: the FDA's Expedited Drug Development Pathway.

Thomas J Moore1, Curt D Furberg.   

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Year:  2012        PMID: 22948694     DOI: 10.1001/jama.2012.9658

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


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  6 in total

Review 1.  The risks of risk aversion in drug regulation.

Authors:  Hans-Georg Eichler; Brigitte Bloechl-Daum; Daniel Brasseur; Alasdair Breckenridge; Hubert Leufkens; June Raine; Tomas Salmonson; Christian K Schneider; Guido Rasi
Journal:  Nat Rev Drug Discov       Date:  2013-11-15       Impact factor: 84.694

2.  Post-approval safety issues with innovative drugs: a European cohort study.

Authors:  Peter G M Mol; Arna H Arnardottir; Domenico Motola; Patrick J Vrijlandt; Ruben G Duijnhoven; Flora M Haaijer-Ruskamp; Pieter A de Graeff; Petra Denig; Sabine M J M Straus
Journal:  Drug Saf       Date:  2013-11       Impact factor: 5.606

3.  Breakthrough Drug Approval Process and Postmarketing ADR Reporting.

Authors:  Danial E Baker
Journal:  Hosp Pharm       Date:  2013-11

4.  Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs.

Authors:  Chul Kim; Vinay Prasad
Journal:  Mayo Clin Proc       Date:  2016-05-10       Impact factor: 7.616

5.  The Role of Vitamin D in the Pathogenesis of Adolescent Idiopathic Scoliosis.

Authors:  Shu-Yan Ng; Josette Bettany-Saltikov; Irene Yuen Kwan Cheung; Karen Kar Yin Chan
Journal:  Asian Spine J       Date:  2018-10-16

6.  Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification.

Authors:  Osemeke U Osokogu; Caitlin Dodd; Alexandra Pacurariu; Florentia Kaguelidou; Daniel Weibel; Miriam C J M Sturkenboom
Journal:  Drug Saf       Date:  2016-09       Impact factor: 5.606

  6 in total

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