200 related articles for article (PubMed ID: 31678263)
1. An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products.
Manning ML; Thompson MD; Saber H; Maher VE; Crich JZ; Leighton JK
Regul Toxicol Pharmacol; 2020 Feb; 110():104511. PubMed ID: 31678263
[TBL] [Abstract][Full Text] [Related]
2. Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold.
Lapteva L; Pariser AR
J Investig Med; 2016 Feb; 64(2):376-82. PubMed ID: 26911627
[TBL] [Abstract][Full Text] [Related]
3. Vaccine INDs: review of clinical holds.
Miller DL; Ross JJ
Vaccine; 2005 Jan; 23(9):1099-101. PubMed ID: 15629351
[TBL] [Abstract][Full Text] [Related]
4. Investigational new drugs submitted to the Food and Drug Administration that are placed on clinical hold: the experience of the Office of Cellular, Tissue and Gene Therapy.
Wonnacott K; Lavoie D; Fiorentino R; McIntyre M; Huang Y; Hirschfeld S
Cytotherapy; 2008; 10(3):312-6. PubMed ID: 18418776
[TBL] [Abstract][Full Text] [Related]
5. The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.
Jarow JP; Casak S; Chuk M; Ehrlich LA; Khozin S
Clin Cancer Res; 2016 May; 22(9):2111-3. PubMed ID: 26783289
[TBL] [Abstract][Full Text] [Related]
6. Regulatory decision strategy for entry of a novel biological therapeutic with a clinically unmonitorable toxicity into clinical trials: pre-IND meetings and a case example.
Black LE; Bendele AM; Bendele RA; Zack PM; Hamilton M
Toxicol Pathol; 1999; 27(1):22-6. PubMed ID: 10367668
[TBL] [Abstract][Full Text] [Related]
7. Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA's Role in Ensuring Patient Safety.
Jarow JP; Lemery S; Bugin K; Lowy N
Ther Innov Regul Sci; 2017 Mar; 51(2):246-249. PubMed ID: 28553566
[TBL] [Abstract][Full Text] [Related]
8. Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators.
Holbein ME
J Investig Med; 2009 Aug; 57(6):688-94. PubMed ID: 19602987
[TBL] [Abstract][Full Text] [Related]
9. Information needed to conduct first-in-human oncology trials in the United States: a view from a former FDA medical reviewer.
Senderowicz AM
Clin Cancer Res; 2010 Mar; 16(6):1719-25. PubMed ID: 20215544
[TBL] [Abstract][Full Text] [Related]
10. Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology.
Shulman DS; Kiwinda LV; Edwards S; Clinton CM; Hunt S; Greenspan L; Lawler KD; Reaman G; Al-Sayegh H; Bona K; O'Neill AF; Shusterman S; Janeway KA; Place AE; Chi SN; Ma C; DuBois SG
Cancer Med; 2021 Apr; 10(7):2310-2318. PubMed ID: 33751835
[TBL] [Abstract][Full Text] [Related]
11. The investigator-sponsored IND in clinical trials.
Haakenson C; Fye CL; Sather MR; Toussaint DJ
Control Clin Trials; 1987 Jun; 8(2):101-9. PubMed ID: 3608504
[TBL] [Abstract][Full Text] [Related]
12. FDA review practices and priorities for drugs used in cancer treatment.
Kobayashi K; DeLap RJ
Ann N Y Acad Sci; 2001 Dec; 949():341-4. PubMed ID: 11795373
[TBL] [Abstract][Full Text] [Related]
13. Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective.
Wu C; Lee SL; Taylor C; Li J; Chan YM; Agarwal R; Temple R; Throckmorton D; Tyner K
J Nat Prod; 2020 Feb; 83(2):552-562. PubMed ID: 31977211
[TBL] [Abstract][Full Text] [Related]
14. Regulatory science: a special update from the United States Food and Drug Administration: Preclinical issues and status of investigation of botanical drug products in the United States.
Wu KM; DeGeorge JG; Atrakchi A; Barry E; Bigger A; Chen C; Du T; Freed L; Geyer H; Goheer A; Jacobs A; Jean D; Rhee H; Osterberg R; Schmidt W; Farrelly JG
Toxicol Lett; 2000 Jan; 111(3):199-202. PubMed ID: 10643863
[TBL] [Abstract][Full Text] [Related]
15. Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.
Perez R; Archdeacon P; Roach N; Goodwin R; Jarow J; Stuccio N; Forrest A
Clin Trials; 2017 Jun; 14(3):225-233. PubMed ID: 28345368
[TBL] [Abstract][Full Text] [Related]
16. PhRMA survey on the conduct of first-in-human clinical trials under exploratory investigational new drug applications.
Karara AH; Edeki T; McLeod J; Tonelli AP; Wagner JA
J Clin Pharmacol; 2010 Apr; 50(4):380-91. PubMed ID: 20097935
[TBL] [Abstract][Full Text] [Related]
17. Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A.
Wu KM; Dou J; Ghantous H; Chen S; Bigger A; Birnkrant D
Regul Toxicol Pharmacol; 2010 Feb; 56(1):1-3. PubMed ID: 19782117
[TBL] [Abstract][Full Text] [Related]
18. Current good manufacturing practice regulation and investigational new drugs. Direct final rule.
Food and Drug Administration. HHS
Fed Regist; 2006 Jan; 71(10):2458-62. PubMed ID: 16479693
[TBL] [Abstract][Full Text] [Related]
19. 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]
20. Building a drug development database: challenges in reliable data availability.
Audibert C; Romine M; Caze A; Daniel G; Leff J; McClellan M
Drug Dev Ind Pharm; 2017 Jan; 43(1):74-78. PubMed ID: 27494335
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
