PPT-Current FDA Enforcement Trends –

Avoiding A Criminal Investigation July 12 2016 Presented by David Acheson Overview Challenges of producing food today Trends in criminal prosecutions How to approach staying out of trouble. 1061 Rockville MD 20852 All comments should be identified with the docket number listed in the notice of availability that is published in the Federal Register For questions rega rding this document contact Michael Ortwerth at 301 796 8220 US Depart 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 Bruce Ross. , . M.A. M.P.H.. Director, India Office. Agenda. Priorities. Challenges of globalization. cGMP. . deficiencies. Comparison. Post inspection regulatory . actions. 2. Advance Regulatory Science: the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated products. 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 . 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 . 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 . 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 . 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 !!!. MSACL. April 4, 2019. Majda Haznadar, Kris Roth, Doug Jeffery. majda.haznadar@fda.hhs.gov. kristian.roth@fda.hhs.gov. doug.jeffery@fda.hhs.gov. www.fda.gov. www.fda.gov. DISCLAIMER. This presentation is intended for informational purposes only and does not constitute legal or regulatory advice. Please see the Federal Food, Drug, and Cosmetic Act and 21 CFR Subchapter H for a full list of requirements by FDA. Jeff Shuren, MD, JD. Center for Devices and Radiological Health. U.S. Food and Drug Administration. www.fda.gov. Who We Are…. CDRH is a team of over 1,700 dedicated, highly-skilled people, including:.