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 *

207 related articles for article (PubMed ID: 31081932)

  • 1. The US Food and Drug Administration's Model-Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact.
    Madabushi R; Benjamin JM; Grewal R; Pacanowski MA; Strauss DG; Wang Y; Zhu H; Zineh I
    Clin Pharmacol Ther; 2019 Jul; 106(1):74-78. PubMed ID: 31081932
    [No Abstract]   [Full Text] [Related]  

  • 2. Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology.
    Bruno R; Jin JY; Maxfield K; Milligan L; Liu C; Wang Y; McKee AE; Zineh I
    Clin Pharmacol Ther; 2019 Jul; 106(1):81-83. PubMed ID: 30951201
    [No Abstract]   [Full Text] [Related]  

  • 3. A one-year perspective on MedWatch: the Food and Drug Administration's new medical products reporting program.
    Gruchalla RS
    J Allergy Clin Immunol; 1995 Jun; 95(6):1153-7. PubMed ID: 7797782
    [No Abstract]   [Full Text] [Related]  

  • 4. The US Food and Drug Administration's Model-Informed Drug Development Meeting Program: From Pilot to Pathway.
    Madabushi R; Benjamin J; Zhu H; Zineh I
    Clin Pharmacol Ther; 2024 Aug; 116(2):278-281. PubMed ID: 38445751
    [No Abstract]   [Full Text] [Related]  

  • 5. Avoiding the regulatory capture of the Food and Drug Administration.
    Egilman DS; Presler AH; Valentin CS
    Arch Intern Med; 2007 Apr; 167(7):732-3. PubMed ID: 17420438
    [No Abstract]   [Full Text] [Related]  

  • 6. The US Food and Drug Administration's expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation.
    Wallach JD; Ross JS; Naci H
    Clin Trials; 2018 Jun; 15(3):243-246. PubMed ID: 29871507
    [No Abstract]   [Full Text] [Related]  

  • 7. How the US drug safety system should be changed.
    Strom BL
    JAMA; 2006 May; 295(17):2072-5. PubMed ID: 16670415
    [No Abstract]   [Full Text] [Related]  

  • 8. The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.
    Wallach JD; Ross JS; Naci H
    Clin Trials; 2018 Jun; 15(3):219-229. PubMed ID: 29871509
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Today's FDA.
    Slater EE
    N Engl J Med; 2005 Jan; 352(3):293-7. PubMed ID: 15659733
    [No Abstract]   [Full Text] [Related]  

  • 10. The US Food and Drug Administration's Real-World Evidence Framework: A Commitment for Engagement and Transparency on Real-World Evidence.
    ElZarrad MK; Corrigan-Curay J
    Clin Pharmacol Ther; 2019 Jul; 106(1):33-35. PubMed ID: 30883700
    [No Abstract]   [Full Text] [Related]  

  • 11. How pharmaceuticals are developed.
    Vander Elst E
    J Am Dent Assoc; 1994 Jan; 125 Suppl():40S-44S. PubMed ID: 8294674
    [No Abstract]   [Full Text] [Related]  

  • 12. Federal Drug Administration authority and the emergency nurse: implications for patient safety.
    Hackenschmidt A
    J Emerg Nurs; 2006 Oct; 32(5):449-50. PubMed ID: 16997042
    [No Abstract]   [Full Text] [Related]  

  • 13. What ails the FDA?
    Okie S
    N Engl J Med; 2005 Mar; 352(11):1063-6. PubMed ID: 15784660
    [No Abstract]   [Full Text] [Related]  

  • 14. Conducting prospective sequential surveillance in real-world dynamic distributed databases.
    Maro JC; Eworuke E; Hou L; Welch EC; Goulding MR; Izem R; Lee JY; Toh S; Fireman B; Nguyen MD
    Pharmacoepidemiol Drug Saf; 2020 Oct; 29(10):1331-1335. PubMed ID: 32449261
    [No Abstract]   [Full Text] [Related]  

  • 15. Regulators scramble to tighten loopholes after heparin debacle.
    Jia H
    Nat Biotechnol; 2008 May; 26(5):477-8. PubMed ID: 18464756
    [No Abstract]   [Full Text] [Related]  

  • 16. Paying for drug approvals--who's using whom?
    Avorn J
    N Engl J Med; 2007 Apr; 356(17):1697-700. PubMed ID: 17435083
    [No Abstract]   [Full Text] [Related]  

  • 17. Reflections on 2013, the beginning of 2014, and the Food and Drug Administration's new expedited approval program known as breakthrough product designation.
    Shader RI
    Clin Ther; 2013 Dec; 35(12):1865-6. PubMed ID: 24332195
    [No Abstract]   [Full Text] [Related]  

  • 18. Pediatric testing of prescription drugs: the Food and Drug Administration's carrot and stick for the pharmaceutical industry.
    Karst KR
    Am Univ Law Rev; 2000; 49():739-72. PubMed ID: 11067732
    [No Abstract]   [Full Text] [Related]  

  • 19. Project Optimus: Is the US Food and Drug Administration Waiving Dose Optimization for Orphan Drugs?
    Wesevich A; Ratain MJ
    JAMA Oncol; 2023 Nov; 9(11):1489-1490. PubMed ID: 37651126
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals.
    Mooghali M; Mohammad A; Wallach JD; Mitchell AP; Ross JS; Ramachandran R
    JAMA Netw Open; 2024 May; 7(5):e249233. PubMed ID: 38691363
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 11.