149 related articles for article (PubMed ID: 38190596)
1. Physicians' Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey.
Dhruva SS; Kesselheim AS; Woloshin S; Ji RZ; Lu Z; Darrow JJ; Redberg RF
Health Aff (Millwood); 2024 Jan; 43(1):27-35. PubMed ID: 38190596
[TBL] [Abstract][Full Text] [Related]
2. Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.
Kesselheim AS; Eddings W; Raj T; Campbell EG; Franklin JM; Ross KM; Fulchino LA; Avorn J; Gagne JJ
PLoS One; 2016; 11(10):e0163339. PubMed ID: 27768700
[TBL] [Abstract][Full Text] [Related]
3. Physician Perspectives on the Food and Drug Administration's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease.
Dhruva SS; Kesselheim AS; Woloshin S; Ji RZ; Lu Z; Darrow JJ; Redberg RF
Clin Pharmacol Ther; 2023 Sep; 114(3):614-617. PubMed ID: 37218658
[TBL] [Abstract][Full Text] [Related]
4. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
Rathi VK; Krumholz HM; Masoudi FA; Ross JS
JAMA; 2015 Aug; 314(6):604-12. PubMed ID: 26262798
[TBL] [Abstract][Full Text] [Related]
5. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Salcher-Konrad M; Naci H; Davis C
Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
[TBL] [Abstract][Full Text] [Related]
6. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
Samuel AM; Rathi VK; Grauer JN; Ross JS
Clin Orthop Relat Res; 2016 Apr; 474(4):1053-68. PubMed ID: 26584802
[TBL] [Abstract][Full Text] [Related]
7. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.
Gopal AD; Rathi VK; Teng CC; Del Priore L; Ross JS
Ophthalmology; 2017 Aug; 124(8):1237-1246. PubMed ID: 28501378
[TBL] [Abstract][Full Text] [Related]
8. Extending the US Food and Drug Administration's Postmarket Authorities.
Fernandez Lynch H; Sachs RE; Lee S; Herder M; Ross JS; Ramachandran R
JAMA Health Forum; 2023 Jun; 4(6):e231313. PubMed ID: 37294583
[TBL] [Abstract][Full Text] [Related]
9. Physician Perceptions of the FDA's Breakthrough Therapy Designation: An Update.
Paquin RS; Boudewyns V; O'Donoghue AC; Aikin KJ
Oncologist; 2022 Feb; 27(1):e85-e88. PubMed ID: 35305103
[TBL] [Abstract][Full Text] [Related]
10. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
Gyawali B; Hey SP; Kesselheim AS
JAMA Intern Med; 2019 Jul; 179(7):906-913. PubMed ID: 31135808
[TBL] [Abstract][Full Text] [Related]
11. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.
Naci H; Smalley KR; Kesselheim AS
JAMA; 2017 Aug; 318(7):626-636. PubMed ID: 28810023
[TBL] [Abstract][Full Text] [Related]
12. Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?
Fox-Rawlings SR; Gottschalk LB; Doamekpor LA; Zuckerman DM
Milbank Q; 2018 Sep; 96(3):499-529. PubMed ID: 30203600
[TBL] [Abstract][Full Text] [Related]
13. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.
Michaeli DT; Michaeli T; Albers S; Boch T; Michaeli JC
Eur J Health Econ; 2023 Nov; ():. PubMed ID: 37962724
[TBL] [Abstract][Full Text] [Related]
14. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.
Rome BN; Kramer DB; Kesselheim AS
JAMA; 2014 Jan 22-29; 311(4):385-91. PubMed ID: 24449317
[TBL] [Abstract][Full Text] [Related]
15. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.
Reynolds IS; Rising JP; Coukell AJ; Paulson KH; Redberg RF
JAMA Intern Med; 2014 Nov; 174(11):1773-9. PubMed ID: 25265209
[TBL] [Abstract][Full Text] [Related]
16. Medical device recalls and the FDA approval process.
Zuckerman DM; Brown P; Nissen SE
Arch Intern Med; 2011 Jun; 171(11):1006-11. PubMed ID: 21321283
[TBL] [Abstract][Full Text] [Related]
17. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.
Basile EM; Tolomeo D; Gluck E
Food Drug Law J; 2009; 64(1):149-69. PubMed ID: 19998744
[TBL] [Abstract][Full Text] [Related]
18. Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA.
Swanson MJ; Johnston JL; Ross JS
Trials; 2021 Nov; 22(1):817. PubMed ID: 34789308
[TBL] [Abstract][Full Text] [Related]
19. The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.
Wallach JD; Ross JS; Naci H
Clin Trials; 2018 Jun; 15(3):219-229. PubMed ID: 29871509
[TBL] [Abstract][Full Text] [Related]
20. Do patients trust the FDA?: a survey assessing how patients view the generic drug approval process.
Kesselheim AS; Gagne JJ; Franklin JM; Eddings W; Fulchino LA; Campbell EG
Pharmacoepidemiol Drug Saf; 2017 Jun; 26(6):694-701. PubMed ID: 28370652
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]