Literature DB >> 27115269

Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation.

Aaron S Kesselheim1, Steven Woloshin2, Wesley Eddings1, Jessica M Franklin1, Kathryn M Ross3, Lisa M Schwartz2.   

Abstract

Mesh:

Year:  2016        PMID: 27115269     DOI: 10.1001/jama.2015.16984

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


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  11 in total

Review 1.  Evaluation of technologies approved for supplemental payments in the United States.

Authors:  Timothy J Judson; Sanket S Dhruva; Rita F Redberg
Journal:  BMJ       Date:  2019-06-17

2.  Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.

Authors:  Huseyin Naci; Olivier J Wouters; Radhika Gupta; John P A Ioannidis
Journal:  Milbank Q       Date:  2017-06       Impact factor: 4.911

3.  The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.

Authors:  Thomas J Hwang; Jonathan J Darrow; Aaron S Kesselheim
Journal:  JAMA       Date:  2017-12-05       Impact factor: 56.272

4.  Physician Interpretation of Data of Uncertain Clinical Utility in Oncology Prescription Drug Promotion.

Authors:  Vanessa Boudewyns; Amie C O'Donoghue; Ryan S Paquin; Kathryn J Aikin; Kate Ferriola-Bruckenstein; Victoria M Scott
Journal:  Oncologist       Date:  2021-09-28

5.  Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.

Authors:  Sanket S Dhruva; Jonathan J Darrow; Aaron S Kesselheim; Rita F Redberg
Journal:  J Gen Intern Med       Date:  2022-02-09       Impact factor: 5.128

Review 6.  Checkpoint Inhibitors, Palliative Care, or Hospice.

Authors:  Mellar P Davis; Rajiv Panikkar
Journal:  Curr Oncol Rep       Date:  2018-01-19       Impact factor: 5.075

7.  Global Development of Anticancer Therapies for Rare Cancers, Pediatric Cancers, and Molecular Subtypes of Common Cancers.

Authors:  H Kim Lyerly; Jun Ren; Renzo Canetta; Gi Hyun Kim; Sumimasa Nagai; Tomohiro Yamaguchi; Ken Hatogai; Hiroshi Katayama; Silvy Da Rocha Dias; Daniel McManus; Kathy Soltys; Zhimin Yang; Olufumilayo Olopade; Nancy Goodman; Greg Reaman; Thomas Gross
Journal:  J Glob Oncol       Date:  2018-12

8.  Physician Perceptions of the FDA's Breakthrough Therapy Designation: An Update.

Authors:  Ryan S Paquin; Vanessa Boudewyns; Amie C O'Donoghue; Kathryn J Aikin
Journal:  Oncologist       Date:  2022-02-03

Review 9.  Breakthroughs in modern cancer therapy and elusive cardiotoxicity: Critical research-practice gaps, challenges, and insights.

Authors:  Ping-Pin Zheng; Jin Li; Johan M Kros
Journal:  Med Res Rev       Date:  2017-09-01       Impact factor: 12.944

10.  Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.

Authors:  Sana R Mostaghim; Joshua J Gagne; Aaron S Kesselheim
Journal:  BMJ       Date:  2017-09-07
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