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Year Number of Results
1987 1
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2008 1
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51 results

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Page 1
BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet].
FDA-NIH Biomarker Working Group. FDA-NIH Biomarker Working Group. Silver Spring (MD): Food and Drug Administration (US); 2016–. Silver Spring (MD): Food and Drug Administration (US); 2016–. PMID: 27010052 Free Books & Documents. Review.
FDA report.
FDA. FDA. J Periodontol. 2006 Feb;77(2):149-51. doi: 10.1902/jop.2006.620004. J Periodontol. 2006. PMID: 16460237 No abstract available.
Reporting Adverse Drug Events.
Feagins LA, Abdelsayed GG, Schairer J; FDA-Related Matters Committee of the American College of Gastroenterology. Feagins LA, et al. Am J Gastroenterol. 2019 Sep;114(9):1411-1413. doi: 10.14309/ajg.0000000000000374. Am J Gastroenterol. 2019. PMID: 31464745 Review. No abstract available.
Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.
U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, et al. Health Qual Life Outcomes. 2006 Oct 11;4:79. doi: 10.1186/1477-7525-4-79. Health Qual Life Outcomes. 2006. PMID: 17034633 Free PMC article.
Understanding Device Development for Gastrointestinal Clinical Care.
Beck KR, Shah ED, Hernandez-Barco YG; ACG FDA-Related Matters Committee. Beck KR, et al. Am J Gastroenterol. 2021 Jun 1;116(6):1107-1109. doi: 10.14309/ajg.0000000000001126. Am J Gastroenterol. 2021. PMID: 34074819 No abstract available.
Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report.
Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process; Wizemann T, editor. Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, et al. Washington (DC): National Academies Press (US); 2011. Washington (DC): National Academies Press (US); 2011. PMID: 24983054 Free Books & Documents. Review.
Understanding Drug Development for Clinical Care.
Shah ED, Hernandez-Barco YG, Beck KR, Levy BH 3rd; ACG FDA-Related Matters Committee. Shah ED, et al. Am J Gastroenterol. 2020 Sep;115(9):1351-1352. doi: 10.14309/ajg.0000000000000683. Am J Gastroenterol. 2020. PMID: 32453059 No abstract available.
51 results