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 *

137 related articles for article (PubMed ID: 38886318)

  • 1. Overdosage Section in US and EU Labeling.
    Condon S; Cantu TG; Constantinou A; Degnan EC; Lungu M; Paglione MG; Parikh SJ; Szewczyk J
    Ther Innov Regul Sci; 2024 Sep; 58(5):946-952. PubMed ID: 38886318
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics.
    Reis-Pardal J; Rodrigues A; Rodrigues E; Fernandez-Llimos F
    Pharmacogenomics J; 2017 Dec; 17(6):488-493. PubMed ID: 27241061
    [TBL] [Abstract][Full Text] [Related]  

  • 3. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016).
    Gnanasakthy A; Barrett A; Evans E; D'Alessio D; Romano CD
    Value Health; 2019 Feb; 22(2):203-209. PubMed ID: 30711065
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006-2018).
    Seo Y; Pacifici E
    Vaccine; 2020 Nov; 38(47):7485-7489. PubMed ID: 33059971
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union.
    Clark MJ; Harris N; Griebsch I; Kaschinski D; Copley-Merriman C
    Health Qual Life Outcomes; 2014 Jul; 12():104. PubMed ID: 24989428
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Utility and importance of animal data in drug product labels.
    Baldrick P
    Regul Toxicol Pharmacol; 2014 Aug; 69(3):546-57. PubMed ID: 24928564
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Classifying Free Texts Into Predefined Sections Using AI in Regulatory Documents: A Case Study with Drug Labeling Documents.
    Gray M; Xu J; Tong W; Wu L
    Chem Res Toxicol; 2023 Aug; 36(8):1290-1299. PubMed ID: 37487037
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Introduction to the new prescription drug labeling by the Food and Drug Administration.
    Lal R; Kremzner M
    Am J Health Syst Pharm; 2007 Dec; 64(23):2488-94. PubMed ID: 18029957
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?
    Maliepaard M; Taams AC; Sung C; Poh J; Yu Y
    Pharmaceut Med; 2019 Oct; 33(5):407-416. PubMed ID: 31933229
    [TBL] [Abstract][Full Text] [Related]  

  • 10. International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.
    Song YK; Han N; Burckart GJ; Oh JM
    Clin Pharmacol Ther; 2020 Mar; 107(3):530-540. PubMed ID: 31544241
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Decision and timing of safety-related labeling changes for new drugs in Japan: Comparison with the United States and the European Union.
    Fukuda K; Narukawa M
    Pharmacoepidemiol Drug Saf; 2023 Dec; 32(12):1331-1340. PubMed ID: 37395168
    [TBL] [Abstract][Full Text] [Related]  

  • 12. A systematic comparison of hepatobiliary adverse drug reactions in FDA and EMA drug labeling reveals discrepancies.
    Wu Y; Xiao W; Tong W; Borlak J; Chen M
    Drug Discov Today; 2022 Jan; 27(1):337-346. PubMed ID: 34607018
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Specific Prescribing Information for Geriatric Use in the 2019 Product Labeling for Novel New Drug Approvals.
    Lisi DM
    Sr Care Pharm; 2021 Sep; 36(9):455-465. PubMed ID: 34452655
    [No Abstract]   [Full Text] [Related]  

  • 14. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
    Iglesias-Lopez C; Obach M; Vallano A; Agustí A
    Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.
    Crider K; Williams J; Qi YP; Gutman J; Yeung L; Mai C; Finkelstain J; Mehta S; Pons-Duran C; Menéndez C; Moraleda C; Rogers L; Daniels K; Green P
    Cochrane Database Syst Rev; 2022 Feb; 2(2022):. PubMed ID: 36321557
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Safety-related regulatory actions for orphan drugs in the US and EU: a cohort study.
    Heemstra HE; Giezen TJ; Mantel-Teeuwisse AK; de Vrueh RL; Leufkens HG
    Drug Saf; 2010 Feb; 33(2):127-37. PubMed ID: 20082539
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.
    Ghadanian M; Schafheutle E
    Ther Innov Regul Sci; 2024 Jan; 58(1):79-113. PubMed ID: 37861859
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.
    Senderowicz AM; Pfaff O
    Clin Cancer Res; 2014 Mar; 20(6):1445-52. PubMed ID: 24634467
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US.
    Christiansen H; De Bruin ML; Frokjaer S; Hallgreen CE
    PLoS One; 2022; 17(4):e0266353. PubMed ID: 35377911
    [TBL] [Abstract][Full Text] [Related]  

  • 20. A Comparison of FDA and EMA Pregnancy and Lactation Labeling.
    Kappel D; Sahin L; Yao L; Thor S; Kweder S
    Clin Pharmacol Ther; 2023 Jun; 113(6):1251-1257. PubMed ID: 36645246
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.