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.
236 related articles for article (PubMed ID: 30231744)
1. An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research: 2003 Through 2014. Sharma K; Harrington A; Worrell S; Bertha A Ther Innov Regul Sci; 2016 Nov; 50(6):697-704. PubMed ID: 30231744 [TBL] [Abstract][Full Text] [Related]
3. How the Critical Path Initiative Addresses CDER's Regulatory Science Needs: Some Illustrative Examples. Geanacopoulos M; Barratt R Ther Innov Regul Sci; 2015 Jul; 49(4):466-472. PubMed ID: 30222436 [TBL] [Abstract][Full Text] [Related]
4. Breakthrough Therapy Designation: CDER Analysis of Requests 4 Years Into the Program. Conrad R; Taylor K; Raggio M; Harrington A; Stark G; Kish A; Bertha A Ther Innov Regul Sci; 2017 Jul; 51(4):509-515. PubMed ID: 30227048 [TBL] [Abstract][Full Text] [Related]
5. Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017-2019. Poddar A; Raggio M; Concato J Ther Innov Regul Sci; 2024 Jan; 58(1):214-221. PubMed ID: 37926768 [TBL] [Abstract][Full Text] [Related]
6. Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview. Woodcock J; Buckman S; Goodsaid F; Walton MK; Zineh I Expert Opin Med Diagn; 2011 Sep; 5(5):369-74. PubMed ID: 23484625 [TBL] [Abstract][Full Text] [Related]
7. Center for Drug Evaluation and Research Perspective on Quality in Clinical Trials. Shapley S; O'Shaughnessy J; Woodcock J Ther Innov Regul Sci; 2017 Jul; 51(4):416-418. PubMed ID: 30227045 [TBL] [Abstract][Full Text] [Related]
9. 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]
10. American Society of Clinical Oncology policy statement: oversight of clinical research. American Society of Clinical Oncology J Clin Oncol; 2003 Jun; 21(12):2377-86. PubMed ID: 12721281 [TBL] [Abstract][Full Text] [Related]
11. Regulatory Forum Opinion Piece*: Transgenic/Alternative Carcinogenicity Assays: A Retrospective Review of Studies Submitted to CDER/FDA 1997-2014. Jacobs AC; Brown PC Toxicol Pathol; 2015 Jul; 43(5):605-10. PubMed ID: 25630682 [TBL] [Abstract][Full Text] [Related]
12. Disputes over coverage of emergency department services: a study of two health maintenance organizations. Gresenz CR; Studdert DM Ann Emerg Med; 2004 Feb; 43(2):155-62. PubMed ID: 14747800 [TBL] [Abstract][Full Text] [Related]
13. Appeals system and its outcomes in national health insurance in Taiwan. Lin SJ; Kuo SC; Yang YH Ann Pharmacother; 2006 Mar; 40(3):506-11. PubMed ID: 16507607 [TBL] [Abstract][Full Text] [Related]