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 *

182 related articles for article (PubMed ID: 8227459)

  • 1. Postmarketing surveillance: curriculum for the clinical pharmacologist. Part I: Postmarketing surveillance within the continuum of the drug approval process.
    Johnson J; Tanner LA
    J Clin Pharmacol; 1993 Oct; 33(10):904-11. PubMed ID: 8227459
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Postmarketing surveillance: curriculum for the clinical pharmacologist. Part II: Clinical and regulatory considerations.
    Johnson JM; Tanner LA
    J Clin Pharmacol; 1993 Nov; 33(11):1015-22. PubMed ID: 8300884
    [TBL] [Abstract][Full Text] [Related]  

  • 3. FDA's Unimproved Enforcement of Postmarketing Requirements and Commitments: Implications for Providers and Patients.
    Dauner DG; Dauner KN; Peterson ALH
    Res Social Adm Pharm; 2020 Jun; 16(6):844-847. PubMed ID: 31812502
    [TBL] [Abstract][Full Text] [Related]  

  • 4. [Tolerance and safety of tramadol use. Results of international studies and data from drug surveillance].
    Cossmann M; Kohnen C; Langford R; McCartney C
    Drugs; 1997; 53 Suppl 2():50-62. PubMed ID: 9190325
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Postmarketing Safety-Related Modifications of Drugs Approved by the US Food and Drug Administration Between 1999 and 2014 Without Randomized Controlled Trials.
    Shepshelovich D; Tibau A; Goldvaser H; Ocana A; Seruga B; Amir E
    Mayo Clin Proc; 2019 Jan; 94(1):74-83. PubMed ID: 30611457
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Postmarketing surveillance for oncology drugs.
    Viale PH; Moore S
    Clin J Oncol Nurs; 2008 Dec; 12(6):877-86. PubMed ID: 19064381
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The role of databases in drug postmarketing surveillance.
    Rodriguez EM; Staffa JA; Graham DJ
    Pharmacoepidemiol Drug Saf; 2001; 10(5):407-10. PubMed ID: 11802586
    [TBL] [Abstract][Full Text] [Related]  

  • 8. SAFETY PROFILE OF OCRIPLASMIN FOR SYMPTOMATIC VITREOMACULAR ADHESION: A Comprehensive Analysis of Premarketing and Postmarketing Experiences.
    Hahn P; Chung MM; Flynn HW; Huang SS; Kim JE; Mahmoud TH; Sadda SR; Dugel PU
    Retina; 2015 Jun; 35(6):1128-34. PubMed ID: 25635575
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Postmarketing Surveillance Studies-An Industry Perspective on Changing Global Requirements and Implications.
    Haque A; Daniel S; Maxwell T; Boerstoel M
    Clin Ther; 2017 Apr; 39(4):675-685. PubMed ID: 28392076
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.
    Sekine S; Pinnow EE; Wu E; Kurtzig R; Hall M; Dal Pan GJ
    Clin Pharmacol Ther; 2016 Jul; 100(1):102-8. PubMed ID: 26853718
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2014 Jun; 79(111):33072-92. PubMed ID: 24922981
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Postmarketing surveillance and reporting of adverse drug events.
    Baer RK
    S D J Med; 2004 Jan; 57(1):13-4. PubMed ID: 14964975
    [No Abstract]   [Full Text] [Related]  

  • 13. Sidelining safety--the FDA's inadequate response to the IOM.
    Smith SW
    N Engl J Med; 2007 Sep; 357(10):960-3. PubMed ID: 17804840
    [No Abstract]   [Full Text] [Related]  

  • 14. FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013.
    Cope JU; Rosenthal GL; Weinel P; Odegaard A; Murphy DM
    Pediatrics; 2015 Dec; 136(6):1125-31. PubMed ID: 26598453
    [TBL] [Abstract][Full Text] [Related]  

  • 15. A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.
    Allan MC
    J Pharm Technol; 1992; 8(5):198-202. PubMed ID: 10171208
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance.
    Voth M; Rosenberg M; Breuer J
    Invest Radiol; 2011 Nov; 46(11):663-71. PubMed ID: 21623211
    [TBL] [Abstract][Full Text] [Related]  

  • 17. The role of the clinical pharmacologist in the management of adverse drug reactions.
    Moore N
    Drug Saf; 2001 Jan; 24(1):1-7. PubMed ID: 11219484
    [TBL] [Abstract][Full Text] [Related]  

  • 18. New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.
    Moneer O; Brown BL; Avorn J; Darrow JJ; Mitra-Majumdar M; Joyce KW; Ross M; Pham C; Kesselheim AS
    Drug Saf; 2022 Apr; 45(4):305-318. PubMed ID: 35182362
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Adverse drug event monitoring at the Food and Drug Administration.
    Ahmad SR
    J Gen Intern Med; 2003 Jan; 18(1):57-60. PubMed ID: 12534765
    [TBL] [Abstract][Full Text] [Related]  

  • 20. The FDA and drug safety: a proposal for sweeping changes.
    Furberg CD; Levin AA; Gross PA; Shapiro RS; Strom BL
    Arch Intern Med; 2006 Oct; 166(18):1938-42. PubMed ID: 17030825
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.