PPT-CVM ONADE eSubmitter Program

June 5 2014 CVM achieved the goals of the 2009 Animal Drug User Fee Act ADUFA Reauthorization Provided an electronic submission tool to the industry Developed an online review environment. Aquaculture Drug Workshop. Bozeman, Montana. July 31, 2013. Meg Oeller, DVM . FDA Center for Veterinary Medicine. 1. Caveat. Please note that these slides have been altered slightly from those used in the presentation at the aquaculture workshop. This was done largely to facilitate making these slides 508 compliant for posting on our website. The pertinent content has not been changed.. 21 CFR 7.40 provides guidance on the policy, procedures, and industry responsibilities for recalls.. Chapter 7 of the Regulatory Procedures Manual outlines the guidance for the procedures necessary for the FDA to classify a recall.. 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 A Communication. Virtual Machine. . . Seminar of “Virtual Machines” course. . ALI MOGHADDAM. University of Science and Technology. Division of Therapeutic Drugs for Non-Food Animals. Office of New Animal Drug Evaluation. USFDA Center for Veterinary Medicine. Effectiveness Evaluation for Therapeutic Drugs for Non-Food Animals. 2. 21 CFR 7.40 provides guidance on the policy, procedures, and industry responsibilities for recalls.. Chapter 7 of the Regulatory Procedures Manual outlines the guidance for the procedures necessary for the FDA to classify a recall.. Animal Biotechnology Interdisciplinary Group. Center for Veterinary Medicine. U.S. Food and Drug Administration. Evgenij A. Evdokimov, PhD. Erik M. Silberhorn, PhD. . Major Statutes Governing Regulation of GE Animals. Center for Veterinary Medicine. Regulating Animal Drugs . Protect the Public Health by ensuring . safe and effective animal drugs reach the market. unsafe and ineffective animal drugs do not reach the market. Director, CVM Office of Research. U.S. Food and Drug Administration. Center for Veterinary Medicine. www.fda.gov. FVM Mission. Promote public health by preventing foodborne illness, fostering good nutrition, and improving the safety and efficacy of animal health products. 11 February 2020 Date of issue: 2 4 February 2020 Host National Society: Mozambique Red Cross Society (Cruz Vermelha de Mozambique, CVM) was established in 1981, and officially recognised by the Gov 1Overview of Overview of Clinical Investigator CIClinical Investigator CIBioresearchMonitoring/ucm133789htmBioresearchMonitoring/ucm133789htmSponsor Contract Research Organizations and Sponsor Contrac e-mail vascocvmgovbrAcademic BackgroundMaster of Science in Law MSL / Rio de Janeiro State University 2007Bachelors degree in Law / Rio de Janeiro State University 2001Master of Business Administratio Office of New Animal Drug Evaluation. Center for Veterinary Medicine. U. S. Food and Drug Administration. June 6, 2012. Embracing New Innovation in Veterinary Drug Evaluation . Safety. Human Food. Target Animal . Feed: CVM’s Data . and . Approaches. Michael H. Henry, Ph.D.. Division of Animal Feeds. Office of Surveillance & Compliance. Center for Veterinary Medicine. Food and Drug Administration. Phone: (240) 453-6861.