551 related articles for article (PubMed ID: 27473417)
1. Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns.
Goldman SA
Drug Saf; 2016 Oct; 39(10):895-901. PubMed ID: 27473417
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. Reporting of deaths during pre-approval clinical trials for advanced HIV-infected populations.
Johann-Liang R; James AN; Behr VL; Struble K; Birnkrant DB
Drug Saf; 2005; 28(7):559-64. PubMed ID: 15963004
[TBL] [Abstract][Full Text] [Related]
4. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
Rossen BR
Food Drug Law J; 2009; 64(1):183-223. PubMed ID: 19998746
[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. [Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].
Eckhardt K; Cremer-Schaeffer P; König J; Paeschke N
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):173-80. PubMed ID: 15726458
[TBL] [Abstract][Full Text] [Related]
7. The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations.
Wittes J; Crowe B; Chuang-Stein C; Guettner A; Hall D; Jiang Q; Odenheimer D; Xia HA; Kramer J
Stat Biopharm Res; 2015 Jul; 7(3):174-190. PubMed ID: 26550466
[TBL] [Abstract][Full Text] [Related]
8. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2010 Sep; 75(188):59935-63. PubMed ID: 20879180
[TBL] [Abstract][Full Text] [Related]
9. Original research: Intravenous ribavirin--review of the FDA's Emergency Investigational New Drug Database (1997-2008) and literature review.
Riner A; Chan-Tack KM; Murray JS
Postgrad Med; 2009 May; 121(3):139-46. PubMed ID: 19491552
[TBL] [Abstract][Full Text] [Related]
10. Investigational new drug applications; clinical holds--FDA. Direct final rule.
Fed Regist; 1998 Dec; 63(239):68676-8. PubMed ID: 10187558
[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. Regulatory issues in pediatric psychopharmacology.
Laughren TP
J Am Acad Child Adolesc Psychiatry; 1996 Oct; 35(10):1276-82. PubMed ID: 8885581
[TBL] [Abstract][Full Text] [Related]
13. Investigational new drug applications; clinical holds; companion document to direct final rule--FDA. Proposed rule.
Fed Regist; 1998 Dec; 63(239):68710-2. PubMed ID: 10187560
[TBL] [Abstract][Full Text] [Related]
14. Aggregate IND Safety Reporting for Smaller Companies and Programs.
Ball G; Li M; Buchanan J; Hendrickson B; Zink RC; Snapinn S; Herson J
Ther Innov Regul Sci; 2024 Mar; 58(2):368-379. PubMed ID: 38190028
[TBL] [Abstract][Full Text] [Related]
15. Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application.
Archdeacon P; Grandinetti C; Vega JM; Balderson D; Kramer JM
Ther Innov Regul Sci; 2014 Mar; 48(2):200-207. PubMed ID: 30227498
[TBL] [Abstract][Full Text] [Related]
16. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2008 Jul; 73(136):40453-63. PubMed ID: 18850678
[TBL] [Abstract][Full Text] [Related]
17. Expediting drug development--the FDA's new "breakthrough therapy" designation.
Sherman RE; Li J; Shapley S; Robb M; Woodcock J
N Engl J Med; 2013 Nov; 369(20):1877-80. PubMed ID: 24224621
[TBL] [Abstract][Full Text] [Related]
18. Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer.
Bonomi P; Stuccio N; Delgra CJ; Chuk MK; Spira A; Deitz AC; Blumenthal GM; Ferris A; Gong Y; He J; Basu Roy U; Selig W
Ther Innov Regul Sci; 2020 Sep; 54(5):1208-1214. PubMed ID: 32865803
[TBL] [Abstract][Full Text] [Related]
19. Second thoughts: do the FDA's responses to a fatal drug trial and the AIDS activist community's doubts about early access to drugs hint at a shift in basic FDA policy?
Lovell MC
Food Drug Law J; 1996; 51(2):273-94. PubMed ID: 11820202
[No Abstract] [Full Text] [Related]
20. Charging for investigational drugs under an investigational new drug application. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2009 Aug; 74(155):40871-900. PubMed ID: 19691172
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
