Literature DB >> 29991565

How to use FDA drug approval documents for evidence syntheses.

Aviv Ladanie1,2, Hannah Ewald1,2,3, Benjamin Kasenda1,4, Lars G Hemkens5.   

Abstract

Mesh:

Year:  2018        PMID: 29991565     DOI: 10.1136/bmj.k2815

Source DB:  PubMed          Journal:  BMJ        ISSN: 0959-8138


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  5 in total

Review 1.  Exploring the Food and Drug Administration's review and approval of Entresto (sacubitril/valsartan).

Authors:  Ashley L Eadie; Keith R Brunt; Matthew Herder
Journal:  Pharmacol Res Perspect       Date:  2021-05

2.  The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs.

Authors:  Aviv Ladanie; Benjamin Speich; Florian Naudet; Arnav Agarwal; Tiago V Pereira; Francesco Sclafani; Juan Martin-Liberal; Thomas Schmid; Hannah Ewald; John P A Ioannidis; Heiner C Bucher; Benjamin Kasenda; Lars G Hemkens
Journal:  Trials       Date:  2018-09-19       Impact factor: 2.279

3.  Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.

Authors:  Aviv Ladanie; Andreas M Schmitt; Benjamin Speich; Florian Naudet; Arnav Agarwal; Tiago V Pereira; Francesco Sclafani; Amanda K Herbrand; Matthias Briel; Juan Martin-Liberal; Thomas Schmid; Hannah Ewald; John P A Ioannidis; Heiner C Bucher; Benjamin Kasenda; Lars G Hemkens
Journal:  JAMA Netw Open       Date:  2020-11-02

4.  Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation.

Authors:  Magdalena Bujar; Neil McAuslane; Patricia Connelly; Stuart R Walker
Journal:  Ther Innov Regul Sci       Date:  2020-05-29       Impact factor: 1.778

5.  Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database.

Authors:  Rikje Ruiter; Jacobus Burggraaf; Robert Rissmann
Journal:  Br J Clin Pharmacol       Date:  2019-02-23       Impact factor: 4.335

  5 in total

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