PPT-FDA Antimicrobials Update

James D McKean DVM JD Associate Director Iowa Pork Industry Center Iowa State University x2mckeaniastateedu Future of Antimicrobials Disclaimer My CRYSTAL BALL may be cracked . 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. . MARCH 2011 Consumer Health Information www.fda.gov/consumer FDA Intends to Remove Unapproved Drugs from Market F DA announced Wednesday remove certain unapproved prescription medicines intended Patricia Kovacevic.   Director, Regulatory . Affairs & Associate . General Counsel. Lorillard Tobacco Company. Presentation before FDLI September 11, 2013 webinar audience. Nothing in this presentation should be construed as forward-looking statements for investment purposes. 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 . 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. Prof. R. K. Dixit. Pharmacology and Therapeutics. K.G.M.U. Lucknow. dixitkumarrakesh@gmail.com. Objectives. After this lecture you will be able to answer. What are antimicrobials, antibiotics, chemotherapeutic agents (Terminologies used in antimicrobial treatment). 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 . and other Antibiotics. Lower Snake River Compensation Plan . Hatchery Production Planning Meeting. May 15-16, 2012. Judicious Use of Antimicrobials. AVMA . AqVMC. Guidelines 2002, revised 2004. Treat as a Last Resort. Nicola . Magrini. and Jane Robertson. Policy, Access and Use Team, EMP. TBS 4 November 2014. Optimize use. Regulatory mechanisms for new antibiotics. Effective low-cost tools for diagnosis and susceptibility testing. Investigational New Drug Application (IND); Summary of regulations and guidelines . Introduction of . cGMP's. /principles of validation . Introduction to QA/QC principles . Good Laboratory Practice (GLP) compliance . and other Antibiotics. Lower Snake River Compensation Plan . Hatchery Production Planning Meeting. May 15-16, 2012. Judicious Use of Antimicrobials. AVMA . AqVMC. Guidelines 2002, revised 2004. Treat as a Last Resort. precision.fda.gov | precisionFDA@fda.hhs.gov | @precisionFDA. Taha A. Kass-Hout, MD, MS. FDA Chief Health Informatics . Officer. Director, FDA’s Office of Health . Informatics. David . Litwack. , PhD. – questions: 1. Give some examples of bacteric idal and bacteriostatic groups / individual antimicrobials. 2. Give some examples of antimicrobials of narrow and broad spectrum f activity 3. Name mec Dmitry Makarov. Department of Feed and Feed Additives safety . . ANTIMICROBIAL RESISTANCE (AMR) IS A GLOBAL THREAT TO MANKIND. *. World Health Organization , author. Report on the burden of endemic health care-associated infection worldwide. Geneva: WHO.