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Literature DB >> 30027239

Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation.

Jeremy Puthumana¹, Joshua D Wallach², Joseph S Ross³.

Abstract

Mesh：

Year: 2018 PMID： 30027239 PMCID： PMC6583484 DOI： 10.1001/jama.2018.7619

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

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Cited

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7 in total

1. 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

2. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

Authors: Joshua J Skydel; Audrey D Zhang; Sanket S Dhruva; Joseph S Ross; Joshua D Wallach
Journal: Clin Trials Date: 2021-04-16 Impact factor: 2.486

3. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.

Authors: Audrey D Zhang; Jeremy Puthumana; Nicholas S Downing; Nilay D Shah; Harlan M Krumholz; Joseph S Ross
Journal: JAMA Netw Open Date: 2020-04-01

4. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.

Authors: Aviv Ladanie; Andreas M Schmitt; Benjamin Speich; Florian Naudet; Arnav Agarwal; Tiago V Pereira; Francesco Sclafani; Amanda K Herbrand; Matthias Briel; Juan Martin-Liberal; Thomas Schmid; Hannah Ewald; John P A Ioannidis; Heiner C Bucher; Benjamin Kasenda; Lars G Hemkens
Journal: JAMA Netw Open Date: 2020-11-02

Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation.

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

2. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

3. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.

4. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.

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

6. Examining the association between oncology drug clinical benefit and the time to public reimbursement.

7. The Assessment of the Innovativeness of a New Medicine in Italy.