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The Food and Drug Administration (FDA) published the Bioresearch Monitoring Technical Conformance Guide in February 2018. The document provides specifications for clinical data submission by pharmaceutical companies used in planning of FDA Bioresearch Monitoring (BIMO) inspections. Three types of information are required: clinical study level.
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Lin Zhang April 08, 2022 Tag: BIMO , FDA , Webinar Favorites The U.S. Food and Drug Administration (FDA) held a webinar on the Bioresearch Monitoring program (BIMO) last month (2/16/2022). The FDA BIMO program is a comprehensive on-site inspections and data audit program for the clinical research industry.
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Bioresearch Monitoring Information and Operations (BIMO) Technical Conformance Guide (TCG) outlines the FDA's expectations for the submission of clinical trial data as part of electronic submissions (eSub) for new drug applications (NDAs), supplemental NDAs (sNDAs), biologics license applications (BLAs), and supplemental BLAs (sBLAs).
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Special counsel Robert Hur, who declined to charge President Joe Biden while questioning his mental acuity and memory, testified in a congressional hearing.
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[email protected] U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). 12 APPENDIX 4: EXAMPLES.17. 1 Bioresearch Monitoring Technical Conformance Guide This document provides current Food and Drug Administration (FDA) specifications for.
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The FDA's Bioresearch Monitoring (BIMO) program is aimed at safeguarding the rights, safety, and welfare of clinical trial subjects, as well as ensuring the accuracy and dependability of study data and the compliance of the study with FDA regulations.
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In order to shorten the time for regulatory review of a new drug application (NDA) or biologic license application (BLA), more and more biotech and pharmaceutical companies prepare their Bioresearch Monitoring (BIMO) program packages as part of their initial submissions.
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Watch live coverage as special counsel Robert Hur testifies at a House Judiciary Committee hearing. Hur led an investigation into President Biden's handling of classified documents after he served.
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FY 2020 Clinical Investigator 483 Observation Trends Bioresearch Monitoring (BIMO) Metrics - FY'19 Bioresearch Monitoring (BIMO) Metrics - FY'18 Bioresearch Monitoring (BIMO) Metrics - FY'17.