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.
161 related articles for article (PubMed ID: 37797226)
21. Clinical and regulatory features of drugs not initially approved by the FDA. Wang B; Avorn J; Kesselheim AS Clin Pharmacol Ther; 2013 Dec; 94(6):670-7. PubMed ID: 23963252 [TBL] [Abstract][Full Text] [Related]
22. 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]
23. The US Food and drug administration: drug information resource for formulary recommendations. Marchand HC; Ros BJ; Fine AM; Kremzner ME J Manag Care Pharm; 2012; 18(9):713-8. PubMed ID: 23206214 [TBL] [Abstract][Full Text] [Related]
25. Demystifying the U.S. Food and Drug Administration: understanding regulatory pathways. Naghshineh N; Brown S; Cederna PS; Levi B; Lisiecki J; D'Amico RA; Hume KM; Seward W; Rubin JP Plast Reconstr Surg; 2014 Sep; 134(3):559-569. PubMed ID: 25158712 [TBL] [Abstract][Full Text] [Related]
26. Tutorial on How the US Food and Drug Administration Regulates Parenteral Nutrition Products. Tabor E JPEN J Parenter Enteral Nutr; 2020 Feb; 44(2):174-181. PubMed ID: 31971272 [TBL] [Abstract][Full Text] [Related]
28. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. Gupta R; Dhruva SS; Fox ER; Ross JS J Manag Care Spec Pharm; 2017 Oct; 23(10):1066-1076. PubMed ID: 28944731 [TBL] [Abstract][Full Text] [Related]
29. How are drugs approved? Part 1: the evolution of the Food and Drug Administration. Howland RH J Psychosoc Nurs Ment Health Serv; 2008 Jan; 46(1):15-9. PubMed ID: 18251347 [TBL] [Abstract][Full Text] [Related]
30. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. Sacks LV; Shamsuddin HH; Yasinskaya YI; Bouri K; Lanthier ML; Sherman RE JAMA; 2014 Jan 22-29; 311(4):378-84. PubMed ID: 24449316 [TBL] [Abstract][Full Text] [Related]
31. Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions. Bennett CL; Schoen MW; Hoque S; Witherspoon BJ; Aboulafia DM; Hwang CS; Ray P; Yarnold PR; Chen BK; Schooley B; Taylor MA; Wyatt MD; Hrushesky WJ; Yang YT Lancet Oncol; 2020 Dec; 21(12):e575-e588. PubMed ID: 33271114 [TBL] [Abstract][Full Text] [Related]
32. New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact. Bugin K; Woodcock J; Stein P; Sharma K; Tyberg Y Ther Innov Regul Sci; 2021 Mar; 55(2):440-446. PubMed ID: 33105018 [TBL] [Abstract][Full Text] [Related]
33. Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration. Hutchinson N; Carlisle B; Doussau A; Bosan R; Gumnit E; MacPherson A; Fergusson DA; Kimmelman J JAMA Netw Open; 2021 May; 4(5):e2110456. PubMed ID: 34003270 [TBL] [Abstract][Full Text] [Related]
34. Governmental Regulations and Increasing Food and Drug Administration Oversight of Regenerative Medicine Products: What's New in 2020? Fang WH; Vangsness CT Arthroscopy; 2020 Oct; 36(10):2765-2770. PubMed ID: 32442713 [TBL] [Abstract][Full Text] [Related]
35. Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals. Harapanhalli RS Semin Nucl Med; 2010 Sep; 40(5):364-84. PubMed ID: 20674596 [TBL] [Abstract][Full Text] [Related]
36. A drug's life: the pathway to drug approval. Keng MK; Wenzell CM; Sekeres MA Clin Adv Hematol Oncol; 2013 Oct; 11(10):646-55. PubMed ID: 24518374 [TBL] [Abstract][Full Text] [Related]
37. Review of the Food and Drug Administration's Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Mid-Cycle Communications. Hoffman RD; Beattie SD; Camp JR; Fuhs JV Ther Innov Regul Sci; 2023 Jul; 57(4):689-701. PubMed ID: 37014601 [TBL] [Abstract][Full Text] [Related]
38. Missing data issues at the FDA Center for Biologics Evaluation and Research. Scott JA; Hsu H J Biopharm Stat; 2011 Mar; 21(2):196-201. PubMed ID: 21390996 [TBL] [Abstract][Full Text] [Related]
39. Regulating Generic Ophthalmologic Drug Bioequivalence-Envisioning Accessibility for Patients. Luke MC; Kozak D J Ocul Pharmacol Ther; 2021 Apr; 37(3):157-161. PubMed ID: 33332225 [TBL] [Abstract][Full Text] [Related]
40. Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products. Moore TJ; Mouslim MC; Blunt JL; Alexander GC; Shermock KM JAMA Intern Med; 2021 Jan; 181(1):52-60. PubMed ID: 33031559 [TBL] [Abstract][Full Text] [Related] [Previous] [Next] [New Search]