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.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

129 related articles for article (PubMed ID: 15506166)

  • 1. Explaining reductions in FDA drug review times: PDUFA matters.
    Olson MK
    Health Aff (Millwood); 2003; Suppl Web Exclusives():W4-S1-W4-S2. PubMed ID: 15506166
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Approval times for new drugs: does the source of funding for FDA staff matter?
    Carpenter D; Chernew M; Smith DG; Fendrick AM
    Health Aff (Millwood); 2003; Suppl Web Exclusives():W3-618-24. PubMed ID: 15506165
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The prescription Drug User Fee Act of 1992 and the new drug development process.
    Kaitin KI
    Am J Ther; 1997; 4(5-6):167-72. PubMed ID: 10423607
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The Prescription Drug User Fee Act: Much More Than User Fees.
    Mitchell AP; Trivedi NU; Bach PB
    Med Care; 2022 Apr; 60(4):287-293. PubMed ID: 35149663
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Managing delegation in the FDA: reducing delay in new-drug review.
    Olson MK
    J Health Polit Policy Law; 2004 Jun; 29(3):397-430. PubMed ID: 15328872
    [TBL] [Abstract][Full Text] [Related]  

  • 6. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
    Darrow JJ; Avorn J; Kesselheim AS
    JAMA; 2020 Jan; 323(2):164-176. PubMed ID: 31935033
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.
    Berndt ER; Gottschalk AH; Philipson TJ; Strobeck MW
    Nat Rev Drug Discov; 2005 Jul; 4(7):545-54. PubMed ID: 16052239
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Drug-review deadlines and safety problems.
    Carpenter D; Zucker EJ; Avorn J
    N Engl J Med; 2008 Mar; 358(13):1354-61. PubMed ID: 18367738
    [TBL] [Abstract][Full Text] [Related]  

  • 9. The Prescription Drug User Fee Act: Cause for Concern?
    Gabay M
    Hosp Pharm; 2018 Apr; 53(2):88-89. PubMed ID: 29581600
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Controversy still swirls around FDA user fees: since 1992, the prescription drug user fee act and reauthorizations have sped up new drug approvals--but does speed equal safety?
    Ullman K
    Ann Neurol; 2013 Nov; 74(5):A10-1. PubMed ID: 24353218
    [No Abstract]   [Full Text] [Related]  

  • 11. Regulatory watch: FDA PDUFA goals missed.
    Hay M
    Nat Rev Drug Discov; 2009 Jan; 8(1):10. PubMed ID: 19116619
    [No Abstract]   [Full Text] [Related]  

  • 12. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Jul; 73(133):39588-611. PubMed ID: 18850675
    [TBL] [Abstract][Full Text] [Related]  

  • 13. FDA reform signed into law. Food and Drug Administration.
    James JS
    AIDS Treat News; 1997 Dec; (No 284):6-7. PubMed ID: 11364915
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Economic Impacts of the Generic Drug User Fee Act Fee Structure.
    Dong K; Boehm G; Zheng Q
    Value Health; 2017 Jun; 20(6):792-798. PubMed ID: 28577697
    [TBL] [Abstract][Full Text] [Related]  

  • 15. FDA and drug safety: new Tufts study challenges critics of the Prescription Drug User Fee Act.
    Lee R
    J Law Med Ethics; 2006; 34(1):131-4. PubMed ID: 16489994
    [No Abstract]   [Full Text] [Related]  

  • 16. Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics.
    Woo J; Luan JJ; Li Z; Grosser S; Peters J; Chazin H
    Ther Innov Regul Sci; 2019 Sep; 53(5):696-700. PubMed ID: 30360656
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Staff resources speed FDA drug review: a critical analysis of the returns to resources in approval regulation.
    Carpenter D
    J Health Polit Policy Law; 2004 Jun; 29(3):431-42; discussion 443-50. PubMed ID: 15328873
    [No Abstract]   [Full Text] [Related]  

  • 18. The Prescription Drug User Fee Act of 1992: speeding up the drug approval process.
    Bierut MB
    Healthspan; 1992 Dec; 9(11):12-4. PubMed ID: 10123552
    [No Abstract]   [Full Text] [Related]  

  • 19. 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]  

  • 20. The Prescription Drug User Fee Act of 1992. A 5-year experiment for industry and the FDA.
    Shulman SR; Kaitin KI
    Pharmacoeconomics; 1996 Feb; 9(2):121-33. PubMed ID: 10160091
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.