A great resource! Read on.
From: “Dr. David Scarfe”
Date: 3 August 2013 6:02:38 AWST
Subject: AquaVetMed e-News: FDA Drug Instructional Videos on-line
August 2, 2013
FDA Veterinary Drug Instructional Videos
The U.S. Food & Drug Agency, Center for Veterinary Medicine has recently made a number of instructional videos available on-line. These have been produced in fulfillment of the FDA’s mission to protect U.S. human and animal health by assuring the safety, efficacy, and quality of animal drugs, including drugs intended for food-producing animals, and the safety of animal feeds and pet foods.
Many of the videos are 10-15 minutes in length, but very effectively explain the core issues of FDA programs for approving drugs, and monitoring products after they have been placed on the market. Many of them are directly relevant to aquatic veterinary medicine. These videos also describe how CVM supports continuing efforts to reduce trade barriers and promote harmonization of international standards and guidelines.
The following are available at http://tinyurl.com/kwelp7h:
· Welcome to the Center for Veterinary Medicine (Bernadette M. Dunham, DVM, PhD)
· Current Good Manufacturing Practices ( Dr. Gabriel Davila)
· Chemistry, Manufacturing, and Controls and Good Manufacturing Practices: The Big Picture of a Long-Term Commitment (Elizabeth Pollina Cormier, PhD)
· Effectiveness Evaluation for Therapeutic Drugs for Food Animals (Emily Smith, DVM)
· Effectiveness Evaluation for Production Drugs (Crystal Groesbeck, PhD)
· Human Food Safety of New Animal Drugs: Microbial Food Safety (Heather Harbottle, PhD)
· Foundations of Regulation (Diane L. Heinz, DVM, MBA)
· Target Animal Safety (Laura L. Hungerford, DVM, MPH, PhD)
· Regulation of Genetically Engineered Animals at FDA: A Case Study (Jeff Jones, DVM, PhD)
· Effectiveness Evaluation for Therapeutic Drugs for Non-Food Animals (Christopher Loss, DVM)
· Aquaculture (Jennifer Matysczak, VMD)
· The National Antimicrobial Resistance Monitoring System – Tracking Antimicrobial Resistance in the Food Supply (Patrick McDermott, PhD)
· Medicated Feeds Overview (Dr. Dragan Momcilovic and Dr. Gabriel Davila)
· Advertising Issues, Effectiveness Claims (Mike Murphy, DVM, JD, PhD)
· Lifecycle-Based Approach to Regulating Product Quality – An International Perspective (Dr. Michael E. Oehlsen)
· An Overview of Minor Use and Minor Species Issues in the U.S.A. (Meg Oeller, DVM)
· Human Food Safety of New Animal Drugs: Residue Chemistry (Julia A. Oriani, PhD)
· Regulating Animal Drugs (Brandi Robinson)
· Regulation of Animal Biotechnology at FDA: An Overview (Eric Schulze, PhD)
· Labeling Issues (Suzanne Sechen, PhD)
· Environmental Impact (Risk) Assessment of Veterinary Pharmaceuticals (Eric Silberhorn, PhD)
· Introduction to CVM International Programs Webpage (Merton V. Smith, PhD, JD)
· Governance of Veterinary Medicinal Products: Need to Leverage Resources (Merton V. Smith, PhD, JD)
· CVM Recalls (Kathy Hemming Thompson)
· Overview of CVM Bioresearch Monitoring ( Vernon D. Toelle, PhD)
· Embracing New Innovation in Veterinary Drug Evaluation (Steven D. Vaughn, DVM)
· Regulation of Genetically Engineered Animals at FDA: A Risk-Based Approach (Malini M. Wileman, PhD, RAC)
· Principles of New Animal Drug Effectiveness: An Overview (Linda M. Wilmot, DVM, MS)
· Human Food Safety of New Animal Drugs: Toxicology Assessment (Tong Zhou, PhD, DABT)
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