PPT-Recent FDA Announcements – Agricultural Water

Recent FDA Announcements Agricultural Water SUPPLEMENTAL MATERIAL Version 06212019 Business Size Compliance Dates For Most Requirements Water Related Compliance Dates All other businesses gt500K. 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. experiences and challenges in Sri Lanka . Chandika Vilashini Ethugala. . (. Bsc. sp . Hons. , MPA, . Mphil. ). Director. Irrigation and Water Resources Management. Sri Lanka. Currency. : Sri Lankan Rupee. Jeff Shuren, MD, JD. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Patients are at the Heart of What We Do. CDRH Vision: Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world . 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 . 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 . 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 . 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. in. S. K. Hamilton, J. E. Doll, and G. P. Robertson, editors. The ecology of agricultural landscapes: long-term research on the path to sustainability. Oxford University Press, New York, New York, . 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. . Industry perspectives on the use of risk-based approaches. Jennifer McEntire, PhD. VP, Food Safety. United Fresh Produce Association. FVIAC. Aug 14, 2019. Key Points. Everyone knows ag water quality is important to food safety.