Literature DB >> 29209711

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

Thomas J Hwang1, Jonathan J Darrow1, Aaron S Kesselheim1.   

Abstract

Mesh：

Year:  2017        PMID： 29209711      PMCID： PMC5820715          DOI： 10.1001/jama.2017.14896

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


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  3 in total

1.  A Randomized Trial Testing US Food and Drug Administration "Breakthrough" Language.

Authors:  Tamar Krishnamurti; Steven Woloshin; Lisa M Schwartz; Baruch Fischhoff
Journal:  JAMA Intern Med       Date:  2015-11       Impact factor: 21.873

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

Authors:  Aaron S Kesselheim; Steven Woloshin; Wesley Eddings; Jessica M Franklin; Kathryn M Ross; Lisa M Schwartz
Journal:  JAMA       Date:  2016-04-12       Impact factor: 56.272

3.  Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

Authors:  Nicholas S Downing; Nilay D Shah; Jenerius A Aminawung; Alison M Pease; Jean-David Zeitoun; Harlan M Krumholz; Joseph S Ross
Journal:  JAMA       Date:  2017-05-09       Impact factor: 56.272
  3 in total
  11 in total

1.  An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.

Authors:  Emerson Y Chen; Vikram Raghunathan; Vinay Prasad
Journal:  JAMA Intern Med       Date:  2019-07-01       Impact factor: 21.873

2.  Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval.

Authors:  Roberta Joppi; Vittorio Bertele; Tommaso Vannini; Silvio Garattini; Rita Banzi
Journal:  Br J Clin Pharmacol       Date:  2019-12-16       Impact factor: 4.335

3.  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

4.  New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.

Authors:  Osman Moneer; Beatrice L Brown; Jerry Avorn; Jonathan J Darrow; Mayookha Mitra-Majumdar; Krysten W Joyce; Murray Ross; Catherine Pham; Aaron S Kesselheim
Journal:  Drug Saf       Date:  2022-02-19       Impact factor: 5.228

5.  The endless frontier? The recent increase of R&D productivity in pharmaceuticals.

Authors:  Fabio Pammolli; Lorenzo Righetto; Sergio Abrignani; Luca Pani; Pier Giuseppe Pelicci; Emanuele Rabosio
Journal:  J Transl Med       Date:  2020-04-09       Impact factor: 5.531

6.  The Potential Benefit of Expedited Development and Approval Programs in Precision Medicine.

Authors:  Ariel Kantor; Susanne B Haga
Journal:  J Pers Med       Date:  2021-01-14

Review 7.  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

8.  Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe.

Authors:  Rick A Vreman; Huseyin Naci; Wim G Goettsch; Aukje K Mantel-Teeuwisse; Sebastian G Schneeweiss; Hubert G M Leufkens; Aaron S Kesselheim
Journal:  Clin Pharmacol Ther       Date:  2020-04-20       Impact factor: 6.875

9.  Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways.

Authors:  Erica M Cox; Anita V Edmund; Erica Kratz; Sarah H Lockwood; Aishwarya Shankar
Journal:  Clin Transl Sci       Date:  2020-02-06       Impact factor: 4.689

10.  A novel data mining application to detect safety signals for newly approved medications in routine care of patients with diabetes.

Authors:  Michael Fralick; Martin Kulldorff; Donald Redelmeier; Shirley V Wang; Seanna Vine; Sebastian Schneeweiss; Elisabetta Patorno
Journal:  Endocrinol Diabetes Metab       Date:  2021-04-06
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