245 related articles for article (PubMed ID: 35900722)
1. Analysis of FDA's Accelerated Approval Program Performance December 1992-December 2021.
Beakes-Read G; Neisser M; Frey P; Guarducci M
Ther Innov Regul Sci; 2022 Sep; 56(5):698-703. PubMed ID: 35900722
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. 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]
4. 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]
5. Great Trees Require Strong Roots: Evaluating Data and Delegation Doctrine Underlying Proposed Reforms to FDA's Accelerated Approval Program.
Deshmukh AD
J Law Med Ethics; 2023; 51(4):920-925. PubMed ID: 38477271
[TBL] [Abstract][Full Text] [Related]
6. US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018.
Omae K; Onishi A; Sahker E; Furukawa TA
JAMA Netw Open; 2022 Sep; 5(9):e2230973. PubMed ID: 36083581
[TBL] [Abstract][Full Text] [Related]
7. Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval.
Liu ITT; Kesselheim AS; Cliff ERS
JAMA; 2024 May; 331(17):1471-1479. PubMed ID: 38583175
[TBL] [Abstract][Full Text] [Related]
8. Reforming Reimbursement for the US Food and Drug Administration's Accelerated Approval Program to Support State Medicaid Programs.
Sachs RE; Donohue JM; Dusetzina SB
JAMA Health Forum; 2022 Nov; 3(11):e224115. PubMed ID: 36399351
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. 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]
11. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study.
Mooghali M; Mitchell AP; Skydel JJ; Ross JS; Wallach JD; Ramachandran R
BMJ Med; 2024; 3(1):e000802. PubMed ID: 38596814
[TBL] [Abstract][Full Text] [Related]
12. FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence.
Sasinowski FJ; Varond AJ
Food Drug Law J; 2016 Aug; 71(1):135-157. PubMed ID: 29693934
[TBL] [Abstract][Full Text] [Related]
13. Improving Food and Drug Administration-Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval.
Neumann PJ; Crummer E; Chambers JD; Tunis SR
Milbank Q; 2023 Dec; 101(4):1047-1075. PubMed ID: 37644739
[TBL] [Abstract][Full Text] [Related]
14. Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform.
Herder M
J Law Med Ethics; 2023; 51(4):900-919. PubMed ID: 38477277
[TBL] [Abstract][Full Text] [Related]
15. Accelerated approval of oncology products: the food and drug administration experience.
Johnson JR; Ning YM; Farrell A; Justice R; Keegan P; Pazdur R
J Natl Cancer Inst; 2011 Apr; 103(8):636-44. PubMed ID: 21422403
[TBL] [Abstract][Full Text] [Related]
16. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.
Skydel JJ; Egilman AC; Wallach JD; Ramachandran R; Gupta R; Ross JS
JAMA Health Forum; 2022 May; 3(5):e221158. PubMed ID: 35977252
[TBL] [Abstract][Full Text] [Related]
17. Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval.
Sachs RE; Gavulic KA; Donohue JM; Dusetzina SB
JAMA Health Forum; 2021 Oct; 2(10):e213177. PubMed ID: 35977163
[TBL] [Abstract][Full Text] [Related]
18. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
Rossen BR
Food Drug Law J; 2009; 64(1):183-223. PubMed ID: 19998746
[TBL] [Abstract][Full Text] [Related]
19. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
Darrow JJ; Avorn J; Kesselheim AS
JAMA; 2020 Jan; 323(2):164-176. PubMed ID: 31935033
[TBL] [Abstract][Full Text] [Related]
20. Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits.
Sachs RE; Jazowski SA; Gavulic KA; Donohue JM; Dusetzina SB
J Health Polit Policy Law; 2022 Dec; 47(6):673-690. PubMed ID: 35867545
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]