Detalhe da pesquisa
1.
Trend changes of national zolpidem users and exposure cases after FDA drug safety communications.
Pharmacoepidemiol Drug Saf
; 30(11): 1551-1559, 2021 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-34382718
2.
FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes.
Pharmacoepidemiol Drug Saf
; 29(9): 1022-1029, 2020 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-32790031
3.
A systematic assessment of key design and performance characteristics of drug exposure registries requested by the U.S. Food and Drug Administration.
Pharmacoepidemiol Drug Saf
; 27(3): 299-306, 2018 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-29349833
4.
Trends in pediatric nonprescription analgesic/antipyretic exposures during the COVID-19 pandemic.
Clin Toxicol (Phila)
; 61(3): 190-199, 2023 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-36892525
5.
Assessment of the Impact of Mandated Postmarketing Pediatric-Focused Safety Reviews on Safety-Related Regulatory Actions 2013-2019.
Clin Pharmacol Ther
; 113(6): 1368-1377, 2023 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-37021630
6.
Pediatric cardiovascular safety: challenges in drug and device development and clinical application.
Am Heart J
; 164(4): 481-92, 2012 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-23067905
7.
Disproportionality analysis for signal detection of implantable cardioverter-defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System.
Pharmacoepidemiol Drug Saf
; 21(1): 87-93, 2012 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-22095760
8.
Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration.
Drug Saf
; 45(2): 169-180, 2022 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-35113347
9.
The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes.
Clin Pharmacol Ther
; 110(6): 1512-1525, 2021 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-34057195
10.
A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.
Drug Saf
; 44(7): 743-751, 2021 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-33904111
11.
Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank.
Am Heart J
; 160(4): 619-26, 2010 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-20934554
12.
Planning the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: a Cardiac Safety Research Consortium "Incubator" Think Tank.
Am Heart J
; 159(1): 17-24, 2010 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-20102862
13.
Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities.
Clin Pharmacol Ther
; 108(6): 1243-1253, 2020 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-32557564
14.
Increasing participation of women in early phase clinical trials approved by the FDA.
Womens Health Issues
; 19(2): 89-93, 2009.
Artigo
em Inglês
| MEDLINE | ID: mdl-19272558
15.
Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014.
Clin Pharmacol Ther
; 104(2): 390-400, 2018 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-29266187
16.
Intravascular gamma radiation for in-stent restenosis in saphenous-vein bypass grafts.
N Engl J Med
; 346(16): 1194-9, 2002 Apr 18.
Artigo
em Inglês
| MEDLINE | ID: mdl-11961147
17.
The Food and Drug Administration Office of Women's Health: impact of science on regulatory policy.
J Womens Health (Larchmt)
; 16(6): 807-17, 2007.
Artigo
em Inglês
| MEDLINE | ID: mdl-17678451
18.
Preprocedure hyperglycemia is more strongly associated with restenosis in diabetic patients after percutaneous coronary intervention than is hemoglobin A1C.
Cardiovasc Revasc Med
; 8(1): 15-20, 2007.
Artigo
em Inglês
| MEDLINE | ID: mdl-17293264
19.
Efficacy of sirolimus-eluting stents compared with bare metal stents for saphenous vein graft intervention.
Am J Cardiol
; 97(1): 34-7, 2006 Jan 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-16377280
20.
Twelve versus six months of clopidogrel to reduce major cardiac events in patients undergoing gamma-radiation therapy for in-stent restenosis: Washington Radiation for In-Stent restenosis Trial (WRIST) 12 versus WRIST PLUS.
Circulation
; 106(7): 776-8, 2002 Aug 13.
Artigo
em Inglês
| MEDLINE | ID: mdl-12176945