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 *

399 related articles for article (PubMed ID: 30167510)

  • 1. Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs.
    Van Norman GA
    JACC Basic Transl Sci; 2016 Apr; 1(3):170-179. PubMed ID: 30167510
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices.
    Van Norman GA
    JACC Basic Transl Sci; 2016 Jun; 1(4):277-287. PubMed ID: 30167516
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the "Right to Try".
    Van Norman GA
    JACC Basic Transl Sci; 2018 Apr; 3(2):280-293. PubMed ID: 30062214
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Zohydro approval by food and drug administration: controversial or frightening?
    Manchikanti L; Atluri S; Candido KD; Boswell MV; Simopoulos TT; Grider JS; Falco FJ; Hirsch JA
    Pain Physician; 2014; 17(4):E437-50. PubMed ID: 25054396
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Drugs and Devices: Comparison of European and U.S. Approval Processes.
    Van Norman GA
    JACC Basic Transl Sci; 2016 Aug; 1(5):399-412. PubMed ID: 30167527
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Update to Drugs, Devices, and the FDA: How Recent Legislative Changes Have Impacted Approval of New Therapies.
    Van Norman GA
    JACC Basic Transl Sci; 2020 Aug; 5(8):831-839. PubMed ID: 32864509
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The new drug approvals of 1990, 1991, and 1992: trends in drug development.
    Kaitin KI; Manocchia M; Seibring M; Lasagna L
    J Clin Pharmacol; 1994 Feb; 34(2):120-7. PubMed ID: 8163711
    [TBL] [Abstract][Full Text] [Related]  

  • 8. 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]  

  • 9. Expanding Patient Access to Investigational New Drugs: Overview of Intermediate and Widespread Treatment Investigational New Drugs, and Emergency Authorization in Public Health Emergencies.
    Van Norman GA
    JACC Basic Transl Sci; 2018 Jun; 3(3):403-414. PubMed ID: 30062226
    [TBL] [Abstract][Full Text] [Related]  

  • 10. An overview of Food and Drug Administration regulation of drugs, biologics, and devices to be used for management of periodontal diseases.
    Tylenda CA; Weintraub M
    Ann Periodontol; 1997 Mar; 2(1):11-7. PubMed ID: 9151539
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. Expanded Patient Access to Investigational New Devices: Review of Emergency and Nonemergency Expanded Use, Custom, and 3D-Printed Devices.
    Van Norman GA
    JACC Basic Transl Sci; 2018 Aug; 3(4):533-544. PubMed ID: 30175277
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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]  

  • 14. 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]  

  • 15. Unapproved prescription cough, cold, and allergy drug products: recent US Food and Drug Administration regulatory action on unapproved cough, cold, and allergy medications.
    Ostroff C; Lee CE; McMeekin J
    Chest; 2011 Aug; 140(2):295-300. PubMed ID: 21813527
    [TBL] [Abstract][Full Text] [Related]  

  • 16. FDA advisory committees and the new drug approval process.
    Kaitin KI; Melville A; Morris B
    J Clin Pharmacol; 1989 Oct; 29(10):886-90. PubMed ID: 2592579
    [TBL] [Abstract][Full Text] [Related]  

  • 17. From idea to market: the drug approval process.
    Lipsky MS; Sharp LK
    J Am Board Fam Pract; 2001; 14(5):362-7. PubMed ID: 11572541
    [TBL] [Abstract][Full Text] [Related]  

  • 18. The new drug approvals of 1987, 1988, and 1989: trends in drug development.
    Kaitin KI; DiCerbo PA; Lasagna L
    J Clin Pharmacol; 1991 Feb; 31(2):116-22. PubMed ID: 2010558
    [TBL] [Abstract][Full Text] [Related]  

  • 19. The "treatment IND (investigational new drugs)": public policy considerations.
    Roberts C; Palumbo FB
    J Pharm Mark Manage; 1988; 3(1):41-59. PubMed ID: 10290888
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.
    Sacks LV; Shamsuddin HH; Yasinskaya YI; Bouri K; Lanthier ML; Sherman RE
    JAMA; 2014 Jan 22-29; 311(4):378-84. PubMed ID: 24449316
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 20.