BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

132 related articles for article (PubMed ID: 37753899)

  • 1. [Analysis of FDA's Review Concerns for Premarket Pathways and Predicate Product Selection of Device-led Combination Products].
    Tian J
    Zhongguo Yi Liao Qi Xie Za Zhi; 2023 Sep; 47(5):566-570. PubMed ID: 37753899
    [TBL] [Abstract][Full Text] [Related]  

  • 2. [FDA Premarket Pathways for Combination Products].
    Lin Y
    Zhongguo Yi Liao Qi Xie Za Zhi; 2022 Jul; 46(4):355-360. PubMed ID: 35929145
    [TBL] [Abstract][Full Text] [Related]  

  • 3. FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.
    Jenson D; Lester J; Berman ML
    Tob Control; 2016 May; 25(3):246-53. PubMed ID: 27068243
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Dermatologic Device Clearance Within the Food and Drug Administration's 510(k) Pathway.
    Ezaldein HH; Hill ST; Merati M; Suggs A; Reichert B; Scott JF
    Lasers Surg Med; 2020 Nov; 52(9):837-841. PubMed ID: 32221981
    [TBL] [Abstract][Full Text] [Related]  

  • 5. An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
    Peña C; Bowsher K; Costello A; De Luca R; Doll S; Li K; Schroeder M; Stevens T
    IEEE Trans Neural Syst Rehabil Eng; 2007 Sep; 15(3):421-4. PubMed ID: 17894274
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Food and Drug Administration (FDA)'s impact on laboratory performance: FDA's perspective.
    Gutman S
    Clin Chem; 1996 May; 42(5):786-9. PubMed ID: 8653915
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.
    Basile EM; Tolomeo D; Gluck E
    Food Drug Law J; 2009; 64(1):149-69. PubMed ID: 19998744
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Product Development Under FDA's Animal Rule: Understanding FDA's Expectations and Potential Implications for Traditional Development Programs.
    Allio T
    Ther Innov Regul Sci; 2016 Sep; 50(5):660-670. PubMed ID: 30231765
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.
    Dubin JR; Simon SD; Norrell K; Perera J; Gowen J; Cil A
    JAMA Netw Open; 2021 May; 4(5):e217274. PubMed ID: 33956132
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy.
    Scott B
    Food Drug Law J; 2011; 66(3):377-404, ii. PubMed ID: 24505854
    [TBL] [Abstract][Full Text] [Related]  

  • 11. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.
    Roller ST; Pippins RR; Ngai JW
    Food Drug Law J; 2009; 64(3):577-98. PubMed ID: 19999646
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Apr; 65(71):19650-8. PubMed ID: 11010632
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Orbital Implants Receiving Food and Drug Administration Premarket Notification.
    Corcoran Ruiz KM; Vaishnav YJ; Desautels J; Schaefer JL; Migliori ME; Yilmaz T
    Ophthalmic Plast Reconstr Surg; 2022 Sep-Oct 01; 38(5):503-506. PubMed ID: 35699217
    [TBL] [Abstract][Full Text] [Related]  

  • 14. The Complex Process of Using the Interconnected Knee Arthroplasty Device Clearance Pathway.
    Zhu A; Ying X; Pean CA; Sheth NP; Cross MB; Gonzalez Della Valle A; Premkumar A
    HSS J; 2022 Nov; 18(4):462-468. PubMed ID: 36258781
    [No Abstract]   [Full Text] [Related]  

  • 15. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.
    Gopal AD; Rathi VK; Teng CC; Del Priore L; Ross JS
    Ophthalmology; 2017 Aug; 124(8):1237-1246. PubMed ID: 28501378
    [TBL] [Abstract][Full Text] [Related]  

  • 16. The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.
    Purpura CA; Garry EM; Honig N; Case A; Rassen JA
    Clin Pharmacol Ther; 2022 Jan; 111(1):135-144. PubMed ID: 34726771
    [TBL] [Abstract][Full Text] [Related]  

  • 17. FDA use of international standards in the premarket review process.
    Rechen E; Barth DJ; Marlowe D; Kroger L
    Biomed Instrum Technol; 1998; 32(5):518-26. PubMed ID: 9800008
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device.
    Lefkovich C; Rothenberg S
    PLoS One; 2023; 18(3):e0283442. PubMed ID: 36976820
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.
    Kadakia KT; Dhruva SS; Caraballo C; Ross JS; Krumholz HM
    JAMA; 2023 Jan; 329(2):136-143. PubMed ID: 36625810
    [TBL] [Abstract][Full Text] [Related]  

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

    [Next]    [New Search]
    of 7.