Literature DB >> 24670173

New FDA breakthrough-drug category--implications for patients.

Jonathan J Darrow, Jerry Avorn, Aaron S Kesselheim.   

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Year:  2014        PMID: 24670173     DOI: 10.1056/NEJMhle1311493

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


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  23 in total

1.  Real-World Evidence: Promise and Peril For Medical Product Evaluation.

Authors:  Sanket S Dhruva; Joseph S Ross; Nihar R Desai
Journal:  P T       Date:  2018-08

2.  A Time-Trend Economic Analysis of Cancer Drug Trials.

Authors:  Sonya Cressman; George P Browman; Jeffrey S Hoch; Laurel Kovacic; Stuart J Peacock
Journal:  Oncologist       Date:  2015-06-01

3.  Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study.

Authors:  Denis Boucaud-Maitre; Jean-Jacques Altman
Journal:  Eur J Clin Pharmacol       Date:  2016-07-29       Impact factor: 2.953

Review 4.  FDA Policy and Cardiovascular Medicine.

Authors:  Joseph S Ross; Aaron S Kesselheim
Journal:  Circulation       Date:  2015-09-22       Impact factor: 29.690

Review 5.  Big data and black-box medical algorithms.

Authors:  W Nicholson Price
Journal:  Sci Transl Med       Date:  2018-12-12       Impact factor: 17.956

6.  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

7.  Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels.

Authors:  James S Yeh; Ameet Sarpatwari; Aaron S Kesselheim
Journal:  Drug Saf       Date:  2016-08       Impact factor: 5.606

8.  The ethical problem of randomization.

Authors:  Agostino Colli; Luigi Pagliaro; Piergiorgio Duca
Journal:  Intern Emerg Med       Date:  2014-09-07       Impact factor: 3.397

Review 9.  Brief Overview of Approaches and Challenges in New Antibiotic Development: A Focus On Drug Repurposing.

Authors:  Natalie K Boyd; Chengwen Teng; Christopher R Frei
Journal:  Front Cell Infect Microbiol       Date:  2021-05-17       Impact factor: 5.293

10.  Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

Authors:  Aaron S Kesselheim; Bo Wang; Jessica M Franklin; Jonathan J Darrow
Journal:  BMJ       Date:  2015-09-23
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