Literature DB >> 28056124

New "21st Century Cures" Legislation: Speed and Ease vs Science.

Aaron S Kesselheim1, Jerry Avorn1.   

Abstract

Mesh:

Year:  2017        PMID: 28056124     DOI: 10.1001/jama.2016.20640

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


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  23 in total

Review 1.  Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad.

Authors:  Kimberly A Selzman; Hetal Patel; Kenneth Cavanaugh
Journal:  J Interv Card Electrophysiol       Date:  2019-08-16       Impact factor: 1.900

2.  The CECMED Office of Innovation: A Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach.

Authors:  Belkis Romeu; Rafael Perez Cristiá
Journal:  Ther Innov Regul Sci       Date:  2020-07-27       Impact factor: 1.778

3.  Health Information Privacy Laws in the Digital Age: HIPAA Doesn't Apply.

Authors:  Kim Theodos; Scott Sittig
Journal:  Perspect Health Inf Manag       Date:  2020-12-07

4.  Medicines Save, Medicines Kill.

Authors:  Joel Lexchin
Journal:  Drug Saf       Date:  2017-06       Impact factor: 5.606

5.  21st Century Cures Act.

Authors:  Michael Gabay
Journal:  Hosp Pharm       Date:  2017-04

6.  The Potential Return on Public Investment in Detecting Adverse Drug Effects.

Authors:  Krista F Huybrechts; Rishi J Desai; Moa Park; Joshua J Gagne; Mehdi Najafzadeh; Jerry Avorn
Journal:  Med Care       Date:  2017-06       Impact factor: 2.983

7.  From Diagnostic-Therapeutic Pathways to Real-World Data: A Multicenter Prospective Study on Upfront Treatment for EGFR-Positive Non-Small Cell Lung Cancer (MOST Study).

Authors:  Giulia Pasello; Giovanni Vicario; Fable Zustovich; Francesco Oniga; Stefania Gori; Francesco Rosetti; Andrea Bonetti; Adolfo Favaretto; Silvia Toso; Roberta Redelotti; Antonio Santo; Daniele Bernardi; Petros Giovanis; Cristina Oliani; Lorenzo Calvetti; Carlo Gatti; Giovanni Palazzolo; Zora Baretta; Alberto Bortolami; Laura Bonanno; Marco Basso; Jessica Menis; Donatella Da Corte; Stefano Frega; Valentina Guarneri; PierFranco Conte
Journal:  Oncologist       Date:  2019-03-07

Review 8.  Developing Real-world Evidence-Ready Datasets: Time for Clinician Engagement.

Authors:  James M Snyder; Jacob A Pawloski; Laila M Poisson
Journal:  Curr Oncol Rep       Date:  2020-04-16       Impact factor: 5.075

9.  Impact of the black triangle label on prescribing of new drugs in the United Kingdom: lessons for the United States at a time of deregulation.

Authors:  Daniel B Horton; Tobias Gerhard; Amy Davidow; Brian L Strom
Journal:  Pharmacoepidemiol Drug Saf       Date:  2017-08-31       Impact factor: 2.890

10.  Use of Health Care Databases to Support Supplemental Indications of Approved Medications.

Authors:  Michael Fralick; Aaron S Kesselheim; Jerry Avorn; Sebastian Schneeweiss
Journal:  JAMA Intern Med       Date:  2018-01-01       Impact factor: 21.873

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