380 related articles for article (PubMed ID: 32106163)
21. Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source.
Withycombe B; Ovenell M; Meeker A; Ahmed SM; Hartung DM
J Clin Epidemiol; 2016 Sep; 77():78-83. PubMed ID: 27108488
[TBL] [Abstract][Full Text] [Related]
22. Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA.
Michaeli DT; Mills M; Michaeli T; Miracolo A; Kanavos P
Invest New Drugs; 2022 Aug; 40(4):798-809. PubMed ID: 35389145
[TBL] [Abstract][Full Text] [Related]
23. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.
Wallach JD; Egilman AC; Dhruva SS; McCarthy ME; Miller JE; Woloshin S; Schwartz LM; Ross JS
BMJ; 2018 May; 361():k2031. PubMed ID: 29794072
[TBL] [Abstract][Full Text] [Related]
24. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).
Gnanasakthy A; DeMuro C; Clark M; Haydysch E; Ma E; Bonthapally V
J Clin Oncol; 2016 Jun; 34(16):1928-34. PubMed ID: 27069082
[TBL] [Abstract][Full Text] [Related]
25. Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration.
Tibau A; Molto C; Ocana A; Templeton AJ; Del Carpio LP; Del Paggio JC; Barnadas A; Booth CM; Amir E
J Natl Cancer Inst; 2018 May; 110(5):486-492. PubMed ID: 29244173
[TBL] [Abstract][Full Text] [Related]
26. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.
Miller JE; Wilenzick M; Ritcey N; Ross JS; Mello MM
BMJ Open; 2017 Dec; 7(12):e017917. PubMed ID: 29208616
[TBL] [Abstract][Full Text] [Related]
27. Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021.
Monge AN; Sigelman DW; Temple RJ; Chahal HS
JAMA Netw Open; 2022 Nov; 5(11):e2239336. PubMed ID: 36318210
[TBL] [Abstract][Full Text] [Related]
28. Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018.
Heyward J; Moore TJ; Chen J; Meek K; Lurie P; Alexander GC
Ann Intern Med; 2020 Dec; 173(12):956-963. PubMed ID: 32986486
[TBL] [Abstract][Full Text] [Related]
29. Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis.
Naci H; Zhang Y; Woloshin S; Guan X; Xu Z; Wagner AK
Lancet Oncol; 2024 Jun; 25(6):760-769. PubMed ID: 38754451
[TBL] [Abstract][Full Text] [Related]
30. 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]
31. Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.
Naci H; Wouters OJ; Gupta R; Ioannidis JPA
Milbank Q; 2017 Jun; 95(2):261-290. PubMed ID: 28589600
[TBL] [Abstract][Full Text] [Related]
32. Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database.
Ruiter R; Burggraaf J; Rissmann R
Br J Clin Pharmacol; 2019 Apr; 85(4):838-844. PubMed ID: 30681181
[TBL] [Abstract][Full Text] [Related]
33. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.
Downing NS; Aminawung JA; Shah ND; Krumholz HM; Ross JS
JAMA; 2014 Jan 22-29; 311(4):368-77. PubMed ID: 24449315
[TBL] [Abstract][Full Text] [Related]
34. Pediatric drug information available at the time of new drug approvals: A cross-sectional analysis.
Hudgins JD; Bacho MA; Olsen KL; Bourgeois FT
Pharmacoepidemiol Drug Saf; 2018 Feb; 27(2):161-167. PubMed ID: 29148107
[TBL] [Abstract][Full Text] [Related]
35. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.
Rathi VK; Wang B; Ross JS; Downing NS; Kesselheim AS; Gray ST
Otolaryngol Head Neck Surg; 2017 Apr; 156(4):683-692. PubMed ID: 28116974
[TBL] [Abstract][Full Text] [Related]
36. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study.
Zou CX; Becker JE; Phillips AT; Garritano JM; Krumholz HM; Miller JE; Ross JS
Trials; 2018 Oct; 19(1):581. PubMed ID: 30352601
[TBL] [Abstract][Full Text] [Related]
37. Rapid network meta-analysis using data from Food and Drug Administration approval packages is feasible but with limitations.
Wang L; Rouse B; Marks-Anglin A; Duan R; Shi Q; Quach K; Chen Y; Cameron C; Schmid CH; Li T
J Clin Epidemiol; 2019 Oct; 114():84-94. PubMed ID: 31226413
[TBL] [Abstract][Full Text] [Related]
38. ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.
Schwartz LM; Woloshin S; Zheng E; Tse T; Zarin DA
Ann Intern Med; 2016 Sep; 165(6):421-30. PubMed ID: 27294570
[TBL] [Abstract][Full Text] [Related]
39. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.
Phillips AT; Desai NR; Krumholz HM; Zou CX; Miller JE; Ross JS
Trials; 2017 Jul; 18(1):333. PubMed ID: 28720112
[TBL] [Abstract][Full Text] [Related]
40. Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.
Zimmerman KO; Smith PB; McMahon AW; Temeck J; Avant D; Murphy D; McCune S
JAMA Pediatr; 2019 Jan; 173(1):60-67. PubMed ID: 30452504
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]