168 related articles for article (PubMed ID: 26911627)
1. 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]
2. 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]
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. 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]
6. 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]
7. The IND application.
Ferkany JW; Williams M
Curr Protoc Pharmacol; 2008 Sep; Chapter 9():Unit 9.10. PubMed ID: 22294234
[TBL] [Abstract][Full Text] [Related]
8. 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]
9. 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]
10. 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]
11. 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]
12. An Analysis of Antibacterial Drug Development Trends in the United States, 1980-2019.
Dheman N; Mahoney N; Cox EM; Farley JJ; Amini T; Lanthier ML
Clin Infect Dis; 2021 Dec; 73(11):e4444-e4450. PubMed ID: 32584952
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. Investigational new drug application; exception from informed consent; technical amendment--FDA. Final rule.
Fed Regist; 1997 Jun; 62(115):32479. PubMed ID: 10169828
[TBL] [Abstract][Full Text] [Related]
15. Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period.
Jarow JP; Lemery S; Bugin K; Khozin S; Moscicki R
Ther Innov Regul Sci; 2016 Nov; 50(6):705-709. PubMed ID: 27917324
[TBL] [Abstract][Full Text] [Related]
16. 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]
17. Substances doubtful for bulk drug substances list could be INDs.
Thompson CA
Am J Health Syst Pharm; 2016 Apr; 73(8):512-4. PubMed ID: 27045058
[No Abstract] [Full Text] [Related]
18. Communicating with the FDA: the "third rail" of a new model for drug development.
Stanski DR; Orloff JJ
J Clin Pharmacol; 2008 Feb; 48(2):144-5. PubMed ID: 18199890
[No Abstract] [Full Text] [Related]
19. 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]
20. 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]
[Next] [New Search]
