PPT-FDA’s New Final Guidance on

Drug Inspections Anne K Walsh FDLI Enforcement Compliance and Litigation Conference December 89 2014 FDCA Section 704 Inspection a 1 For purposes of enforcement of this chapter officers or employees duly designated by the Secretary upon presenting appropriate credentials and a written notice to the owner operator or agent in charge are authorized . FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10115g3 without seeking prior comment because the agency has determined that prior public participation would not be feasible or appropriate FDA made this determinat 1061 Rockville MD 20852 All comments should be identified with the docket number listed in the notice of availability that is published i n the Federal Register For questions on the content of this guidance contact Advisory Committee Oversight and M com 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. . Director. Policy and Regulations Staff. Center for Veterinary Medicine. Foundations of Regulation. The Federal Government is composed of three distinct branches: legislative, executive, and judicial, which powers are vested by the U.S. Constitution. G:\4156dft.doc 09/30/03 G:\4156dft.doc http://www.fda.gov/cvm/guidance/guidance.htmlhttp://www.cfsan.fda.gov/~dms/guidance.html 09/30/03 G:\4156dft.doc WHAT FILE FORMATS SHOULD I USPage S 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 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 !!!. Director. Policy and Regulations Staff. Center for Veterinary Medicine. Foundations of Regulation. The Federal Government is composed of three distinct branches: legislative, executive, and judicial, which powers are vested by the U.S. Constitution. 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 !!!. 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. PrefacePublic CommentComments and suggestions may be submitted at any time for Agency consideration toDockets Management Branch, Division of Management Systems and Policy, Office ofHuman Resources and and FDA Staff Class II Special Controls Guidance Document Surgical Sutures Guidance for Industry and FDA Document issued on June 3 2003 This document supersedes 147Class II Special Controls Guidance