These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
145 related articles for article (PubMed ID: 39382899)
1. US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement. Alam M; Shi VJ; Maisel-Campbell A; Cressey BD; Nadir U; Koza E; Haq M; Ahmed A; Ma MS; Weil A; Cahn BA; Lee AY; Shapiro S; Poon E JAMA Netw Open; 2024 Oct; 7(10):e2436066. PubMed ID: 39382899 [TBL] [Abstract][Full Text] [Related]
2. Voting behavior during FDA Medical Device Advisory Committee panel meetings. Maisel-Campbell A; Schlessinger DI; Yanes AF; Veledar E; Reynolds KA; Ibrahim SA; Kang BY; Anvery N; Poon E; Alam M PLoS One; 2022; 17(6):e0267134. PubMed ID: 35749461 [TBL] [Abstract][Full Text] [Related]
3. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process. Ciociola AA; Karlstadt RG; Pambianco DJ; Woods KL; Ehrenpreis ED; Am J Gastroenterol; 2014 Oct; 109(10):1508-12. PubMed ID: 25001252 [TBL] [Abstract][Full Text] [Related]
4. Oncologic Drugs Advisory Committee Recommendations and Approval of Cancer Drugs by the US Food and Drug Administration. Tibau A; Ocana A; Anguera G; Seruga B; Templeton AJ; Barnadas A; Amir E JAMA Oncol; 2016 Jun; 2(6):744-50. PubMed ID: 26940233 [TBL] [Abstract][Full Text] [Related]
5. Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021. Daval CJR; Teng TW; Russo M; Kesselheim AS JAMA Health Forum; 2023 Jul; 4(7):e231718. PubMed ID: 37418270 [TBL] [Abstract][Full Text] [Related]
6. Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications. Lee SJ; Cho L; Klang E; Wall J; Rensi S; Glicksberg BS JAMA Netw Open; 2021 Jun; 4(6):e2112562. PubMed ID: 34156454 [TBL] [Abstract][Full Text] [Related]
7. 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]
8. Spinal devices in the United States-investigational device exemption trials and premarket approval of class III devices. Golish SR; Reed ML Spine J; 2017 Jan; 17(1):150-157. PubMed ID: 27737804 [TBL] [Abstract][Full Text] [Related]
9. Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017. Dubin JR; Simon SD; Norrell K; Perera J; Gowen J; Cil A JAMA Netw Open; 2021 May; 4(5):e217274. PubMed ID: 33956132 [TBL] [Abstract][Full Text] [Related]
10. 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]
11. 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]
12. 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]
13. Revisiting financial conflicts of interest in FDA advisory committees. Pham-Kanter G Milbank Q; 2014 Sep; 92(3):446-70. PubMed ID: 25199895 [TBL] [Abstract][Full Text] [Related]
14. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015. Zhang AD; Schwartz JL; Ross JS Milbank Q; 2019 Sep; 97(3):796-819. PubMed ID: 31304643 [TBL] [Abstract][Full Text] [Related]
15. 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]
16. Does seating location impact voting behavior on Food and Drug Administration advisory committees? Broniatowski DA; Magee CL Am J Ther; 2013; 20(5):502-6. PubMed ID: 21642834 [TBL] [Abstract][Full Text] [Related]
17. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. Zheng SY; Dhruva SS; Redberg RF JAMA; 2017 Aug; 318(7):619-625. PubMed ID: 28810022 [TBL] [Abstract][Full Text] [Related]
18. Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. Crider K; Williams J; Qi YP; Gutman J; Yeung L; Mai C; Finkelstain J; Mehta S; Pons-Duran C; Menéndez C; Moraleda C; Rogers L; Daniels K; Green P Cochrane Database Syst Rev; 2022 Feb; 2(2022):. PubMed ID: 36321557 [TBL] [Abstract][Full Text] [Related]