Literature DB >> 23963215

The PCAST report on pharmaceutical innovation: implications for the FDA.

J Woodcock1.   

Abstract

In September 2012, the President's Council of Advisors on Science and Technology (PCAST) released the report "Propelling Innovation in Drug Discovery, Development and Evaluation." A product of discussions with many stakeholders, the report reiterates current problems in drug development, including diminished return on basic biomedical research. The report calls for doubling the current annual output of innovative new medicines--an ambitious goal. Recommendations and resulting initiatives will probably affect the FDA's drug regulatory programs.

Mesh:

Year:  2013        PMID: 23963215     DOI: 10.1038/clpt.2013.88

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  3 in total

1.  Patient-Centered Approach to Benefit-Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non-Small-Cell Lung Cancer.

Authors:  Gokaraju K Raju; Sean Khozin; Karthik Gurumurthi; Reuben Domike; Janet Woodcock
Journal:  JCO Clin Cancer Inform       Date:  2020-08

2.  Timelines of translational science: From technology initiation to FDA approval.

Authors:  Laura M McNamee; Michael Jay Walsh; Fred D Ledley
Journal:  PLoS One       Date:  2017-05-08       Impact factor: 3.240

Review 3.  Integrating Pharmacoproteomics into Early-Phase Clinical Development: State-of-the-Art, Challenges, and Recommendations.

Authors:  Savita Nandal; Tal Burt
Journal:  Int J Mol Sci       Date:  2017-02-19       Impact factor: 5.923

  3 in total

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