Literature DB >> 28114599

Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance.

Robert M Califf1.   

Abstract

Mesh：

Year:  2017        PMID： 28114599     DOI： 10.1001/jama.2017.0410

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


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  8 in total

1.  Discussion: The role, position, and function of the FDA-The past, present, and future.

Authors:  Thomas R Fleming; David L Demets; Lisa M McShane
Journal:  Biostatistics       Date:  2017-07-01       Impact factor: 5.899

2.  Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials.

Authors:  Jeremy M O'Connor; Kristen L Fessele; Jean Steiner; Kathi Seidl-Rathkopf; Kenneth R Carson; Nathan C Nussbaum; Emily S Yin; Kerin B Adelson; Carolyn J Presley; Anne C Chiang; Joseph S Ross; Amy P Abernethy; Cary P Gross
Journal:  JAMA Oncol       Date:  2018-08-09       Impact factor: 31.777

Review 3.  Benefit-risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations.

Authors:  Bethea A Kleykamp; Robert H Dworkin; Dennis C Turk; Zubin Bhagwagar; Penney Cowan; Christopher Eccleston; Susan S Ellenberg; Scott R Evans; John T Farrar; Roy L Freeman; Louis P Garrison; Jennifer S Gewandter; Veeraindar Goli; Smriti Iyengar; Alejandro R Jadad; Mark P Jensen; Roderick Junor; Nathaniel P Katz; J Patrick Kesslak; Ernest A Kopecky; Dmitri Lissin; John D Markman; Michael P McDermott; Philip J Mease; Alec B O'Connor; Kushang V Patel; Srinivasa N Raja; Michael C Rowbotham; Cristina Sampaio; Jasvinder A Singh; Ilona Steigerwald; Vibeke Strand; Leslie A Tive; Jeffrey Tobias; Ajay D Wasan; Hilary D Wilson
Journal:  Pain       Date:  2021-09-09       Impact factor: 7.926

4.  THE GORDON WILSON LECTURE: THE ETHICS OF HUMAN GENOME EDITING.

Authors:  Barry S Coller
Journal:  Trans Am Clin Climatol Assoc       Date:  2020

5.  Lessons on Data Collection and Curation From the NFL Injury Surveillance Program.

Authors:  Nancy A Dreyer; Christina D Mack; Robert B Anderson; Edward M Wojtys; Elliott B Hershman; Allen Sills
Journal:  Sports Health       Date:  2019-07-02       Impact factor: 3.843

6.  Update regarding opportunities for orthopaedic surgeons to contribute to postmarket surveillance of potential safety issues for orthopaedic medical devices marketed in the United States.

Authors:  Vincent J Devlin
Journal:  Arthroplast Today       Date:  2017-10-16

7.  Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016: A cross-sectional study.

Authors:  Aliya C Roginiel; Sanket S Dhruva; Joseph S Ross
Journal:  Medicine (Baltimore)       Date:  2018-10       Impact factor: 1.817

8.  The speed of adoption of new drugs and prescription volume after the amendments in reimbursement coverage: the case of non-vitamin K antagonist oral anticoagulants in South Korea.

Authors:  Kyung-Bok Son
Journal:  BMC Public Health       Date:  2020-05-27       Impact factor: 3.295
  8 in total

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