399 related articles for article (PubMed ID: 22564486)
1. Characteristics of rare disease marketing applications associated with FDA product approvals 2006-2010.
Pariser AR; Slack DJ; Bauer LJ; Warner CA; Tracy LA
Drug Discov Today; 2012 Aug; 17(15-16):898-904. PubMed ID: 22564486
[TBL] [Abstract][Full Text] [Related]
2. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
DiMasi JA
Clin Ther; 2013 Jun; 35(6):808-18. PubMed ID: 23726388
[TBL] [Abstract][Full Text] [Related]
3. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.
Xu K; Coté TR
Brief Bioinform; 2011 Jul; 12(4):341-5. PubMed ID: 21357612
[TBL] [Abstract][Full Text] [Related]
4. What the Orphan Drug Act has done lately for children with rare diseases: a 10-year analysis.
Thorat C; Xu K; Freeman SN; Bonnel RA; Joseph F; Phillips MI; Imoisili MA
Pediatrics; 2012 Mar; 129(3):516-21. PubMed ID: 22371464
[TBL] [Abstract][Full Text] [Related]
5. Rare cancer trial design: lessons from FDA approvals.
Gaddipati H; Liu K; Pariser A; Pazdur R
Clin Cancer Res; 2012 Oct; 18(19):5172-8. PubMed ID: 22718862
[TBL] [Abstract][Full Text] [Related]
6. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.
Sridhara R; Johnson JR; Justice R; Keegan P; Chakravarty A; Pazdur R
J Natl Cancer Inst; 2010 Feb; 102(4):230-43. PubMed ID: 20118413
[TBL] [Abstract][Full Text] [Related]
7. Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.
Khin NA; Yang P; Hung HM; Maung-U K; Chen YF; Meeker-O'Connell A; Okwesili P; Yasuda SU; Ball LK; Huang SM; O'Neill RT; Temple R
Clin Pharmacol Ther; 2013 Aug; 94(2):230-42. PubMed ID: 23588316
[TBL] [Abstract][Full Text] [Related]
8. Characteristics of orphan drug applications that fail to achieve marketing approval in the USA.
Heemstra HE; Leufkens HG; Rodgers RP; Xu K; Voordouw BC; Braun MM
Drug Discov Today; 2011 Jan; 16(1-2):73-80. PubMed ID: 21094692
[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. Impact of Expanded Access on FDA Regulatory Action and Product Labeling.
Jarow JP; Moscicki R
Ther Innov Regul Sci; 2017 Nov; 51(6):787-789. PubMed ID: 30079277
[TBL] [Abstract][Full Text] [Related]
11. Development and approval of vaccines in the United States.
Botstein P
Isr J Med Sci; 1986; 22(3-4):268-71. PubMed ID: 3528047
[TBL] [Abstract][Full Text] [Related]
12. 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]
13. A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance, and Why.
Kashoki M; Hanaizi Z; Yordanova S; Veselý R; Bouygues C; Llinares J; Kweder SL
Clin Pharmacol Ther; 2020 Jan; 107(1):195-202. PubMed ID: 31306483
[TBL] [Abstract][Full Text] [Related]
14. The routes to orphan drug designation--our recent experience at the FDA.
Lev D; Thorat C; Phillips I; Thomas M; Imoisili MA
Drug Discov Today; 2012 Feb; 17(3-4):97-9. PubMed ID: 22210120
[No Abstract] [Full Text] [Related]
15. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.
Schick A; Miller KL; Lanthier M; Dal Pan G; Nardinelli C
Drug Saf; 2017 Jun; 40(6):497-503. PubMed ID: 28342075
[TBL] [Abstract][Full Text] [Related]
16. Security market reaction to FDA fast track designations.
Anderson CW; Zhang Y
J Health Care Finance; 2010; 37(2):27-48. PubMed ID: 21294437
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. Examination of risk evaluation and mitigation strategies and drug safety in the US.
Rodriguez-Monguio R; Spielberger K; Seoane-Vazquez E
Res Social Adm Pharm; 2014; 10(1):232-8. PubMed ID: 23611865
[TBL] [Abstract][Full Text] [Related]
19. Identification of factors associated with first-cycle drug approval rates and regulatory outcomes for new drug applications.
Chang LC; Vanheusen M; Fang X; Breder CD
Pharmacol Res; 2019 Jan; 139():166-172. PubMed ID: 30408574
[TBL] [Abstract][Full Text] [Related]
20. FDA Breakthrough Therapy Designation: Evaluating the Quality of the Evidence behind the Drug Approvals.
Herink MC; Irwin AN; Zumach GM
Pharmacotherapy; 2018 Sep; 38(9):967-980. PubMed ID: 30043413
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
