PDF-FDA Executive Summary

FDA Executive Summary Prepared for the May 1415 2015 meeting of theastroenterologyrologyDevices Panelof theMedical Devices Advisory CommitteeEffective Reprocessing of Endoscopes used in Endoscopic Re. and. IRB Inspections. VA IRB Chairs Meeting. August 2012. Janet Donnelly RAC, CIP. Office of Good Clinical Practice . Office of the Commissioner. Food and Drug Administration . 2. 2. Disclaimer. The views expressed in this presentation are those of the speaker and is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents the presenter's best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. . Judy Z. Segal. Department of English and STS Graduate Program. The University of British Columbia. Discourse of Health and Medicine Symposium. University of Cincinnati. 3 September 2015. Sofia Evelyn Luger . James C. Shehan. Hyman, Phelps & McNamara, P.C.. 700 Thirteenth Street, N.W., Suite 1200. Washington, D.C. 20005, U.S.A.. 202-737-9634 .  . jshehan@hpm.com. October 29, 2014. Agenda. BPCIA Overview. Consumer Health Informationwww.fda.gov/consumerThat’s why FDA is notifying companies to stop marketing 16 unapproved prescription drugs labeled to relieve ear pain and swelling. These ear drops c Vivek Y. Reddy MD. 1. *, Douglas N. Gibson MD. 2. , . Saibal. Kar. 3. , William O’Neill MD. 4. , . Shephal. K. . Doshi. MD. 5. , Rodney P. Horton MD. 6. , Maurice . Buchbinder. MD. 7. , Nicole T. Gordon BSEE. IMPROVING. TRANSPARENCY. AND EFFECTIVENESS. Stephen A. Weitzman, J.D., LL.M. . GOAL. My goal today is to recruit you in an effort to get FDA to devote more resources to meet your information needs. FOIA . Products - 2009 . Tobacco Control Act. - Regulate cigarettes and smokeless . t. obacco . p. roducts . - Ban tobacco-brand . sponsorships of . sports & entertainment . - Ban . free . giveaways. At . the end of this module, you will be . able to recall . FDA regulations . related to pharmaceutical . advertising . with 100% . accuracy. MODULE OBJECTIVE. Pharmaceutical companies spend millions of dollars on drug advertising . Vivek Y. Reddy MD. 1. *, Douglas N. Gibson MD. 2. , . Saibal. Kar. 3. , William O’Neill MD. 4. , . Shephal. K. . Doshi. MD. 5. , Rodney P. Horton MD. 6. , Maurice . Buchbinder. MD. 7. , Nicole T. Gordon BSEE. SUPPLEMENTAL MATERIAL. Version: 12-7-17. Business Size. Compliance Dates. For Most Produce. Proposed . Water Related Compliance. Dates. All. other. businesses (>$500K). 1/26/18. 1/26/22. Small businesses . SUPPLEMENTAL MATERIAL. Version: . 07-31-18. Business Size. Compliance Dates. For Most Produce. Proposed . Water Related Compliance. Dates. All. other. businesses (>$500K). 1/26/18. 1/26/22. Small businesses . October 3, 2017. Stephanie Scarmo, PhD, MPH . Outline. Legislative background. Different models for creating the list. Principles. Final list. Legislative background. Congress did not want to impose barriers to products currently on the market, and thereby legislated a presumption of safety.. Tina Morrison, Ph.D.. Chair, Modeling and Simulation Working Group. Office of the Chief Scientist. Deputy Director, Division of Applied Mechanics. Office of Science and Engineering Laboratories. U.S. Food and Drug Administration. James D. McKean, DVM, JD. Associate Director, Iowa Pork Industry Center, . Iowa State University. x2mckean@iastate.edu. Future of . Antimicrobials. Disclaimer. - My “CRYSTAL BALL” . may be . cracked !!!.