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 *

131 related articles for article (PubMed ID: 36627496)

  • 1. Lessons from CDER's Quality Management Maturity Pilot Programs.
    Maguire J; Fisher A; Harouaka D; Rakala N; Lundi C; Yambot M; Viehmann A; Stiber N; Gonzalez K; Canida L; Buhse L; Kopcha M
    AAPS J; 2023 Jan; 25(1):14. PubMed ID: 36627496
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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]  

  • 3. Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience.
    Fellows M; Friedli T; Li Y; Maguire J; Rakala N; Ritz M; Bernasconi M; Seiss M; Stiber N; Swatek M; Viehmann A
    AAPS J; 2022 Oct; 24(6):111. PubMed ID: 36266372
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.
    Fisher AC; Lee SL; Harris DP; Buhse L; Kozlowski S; Yu L; Kopcha M; Woodcock J
    Int J Pharm; 2016 Dec; 515(1-2):390-402. PubMed ID: 27773853
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Food and Drug Administration: Helping pharmacists ensure that patients receive high-quality medicines.
    Kremzner M
    J Am Pharm Assoc (2003); 2016; 56(2):201-2. PubMed ID: 27000171
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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]  

  • 7. FDA pharmaceutical quality oversight.
    Yu LX; Woodcock J
    Int J Pharm; 2015 Aug; 491(1-2):2-7. PubMed ID: 26027494
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings.
    Tucker J; Fischer T; Upjohn L; Mazzera D; Kumar M
    JAMA Netw Open; 2018 Oct; 1(6):e183337. PubMed ID: 30646238
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Evaluating the Use of KIM-1 in Drug Development and Research Following FDA Qualification.
    Chen R; Sanyal S; Thompson A; Ix JH; Haskins K; Muldowney L; Amur S
    Clin Pharmacol Ther; 2018 Dec; 104(6):1175-1181. PubMed ID: 29761868
    [TBL] [Abstract][Full Text] [Related]  

  • 10. An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs).
    Avila AM; Bebenek I; Bonzo JA; Bourcier T; Davis Bruno KL; Carlson DB; Dubinion J; Elayan I; Harrouk W; Lee SL; Mendrick DL; Merrill JC; Peretz J; Place E; Saulnier M; Wange RL; Yao J; Zhao D; Brown PC
    Regul Toxicol Pharmacol; 2020 Jul; 114():104662. PubMed ID: 32325112
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions.
    Belenos A; Wood EL; Hu M; Kozak D; Xu X; Fisher AC
    AAPS J; 2023 Jan; 25(1):20. PubMed ID: 36702976
    [TBL] [Abstract][Full Text] [Related]  

  • 12. FDA Global Drug Inspections: Surveillance Of Manufacturing Establishments Remains Well Below Pre-COVID-19 Levels.
    Cuddy E; Lu YP; Ridley DB
    Health Aff (Millwood); 2023 Dec; 42(12):1758-1766. PubMed ID: 38048499
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Pharmaceutical trademarks: navigating through the FDA's pilot program.
    Ferrer E
    Drug News Perspect; 2010 Jun; 23(5):333-6. PubMed ID: 20603657
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Piloting social engagement on a federal agency-administered Facebook page.
    Chiu K; Wagner L; Choe L; Chew C; Kremzner M
    J Am Pharm Assoc (2003); 2016; 56(3):330-7. PubMed ID: 27079138
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Protecting the public's health through the application integrity policy.
    Katz PR
    Food Drug Law J; 2010; 65(3):539-43, iii. PubMed ID: 24479240
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period.
    Jarow JP; Lemery S; Bugin K; Khozin S; Moscicki R
    Ther Innov Regul Sci; 2016 Nov; 50(6):705-709. PubMed ID: 27917324
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Generating Model Integrated Evidence for Generic Drug Development and Assessment.
    Zhao L; Kim MJ; Zhang L; Lionberger R
    Clin Pharmacol Ther; 2019 Feb; 105(2):338-349. PubMed ID: 30414386
    [TBL] [Abstract][Full Text] [Related]  

  • 18. An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations.
    Jung M; Swann RM; Anantha MS; Jamali F
    Ther Innov Regul Sci; 2021 Sep; 55(5):907-917. PubMed ID: 34101151
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Pilot projects for improving product tracing along the food supply system.
    Bhatt T; Hickey C; McEntire JC
    J Food Sci; 2013 Dec; 78 Suppl 2():B34-9. PubMed ID: 24171802
    [TBL] [Abstract][Full Text] [Related]  

  • 20.
    ; ; . PubMed ID:
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 7.