U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Slides:

Advertisements

Similar presentations

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDAs website for reference purposes only. It.

Advertisements

U.S. Department of Energy’s Office of Science Archived File The file below has been archived for historical reference purposes only. The content and links.

AAVPT BIENNIAL SYMPOSIUM: “A VETERINARY PRACTITIONER’S VIEW OF COMPOUNDING.” Dennis A. Feinberg, DVM AAVPT 14 th Biennial Symposium, May 16-17, 2005, Rockville,

U.S. Food and Drug Administration Notice: Archived Document. The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Academic Centers Research Node of PECARN (“ACORN”) Supported by Project #U03 MC00001 from the Maternal and Child Health Bureau, Health Resources and Services.

Introduction to Regulation

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

It’s More than Giving Shots to Puppies & Kittens! The Secrets of Veterinary Medicine.

The Academy of Rural Veterinarians

Appropriate Use of Antibiotics A Veterinary Curriculum and Other Educational Activities Jennifer Nunnery, DVM ATPM Fellow FoodNet/NARMS Unit Foodborne.

CBER U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Science at the FDA: Update for the Science Board Jesse L. Goodman, MD, MPH Chief Scientist and Deputy Commissioner for Science and Public Health November.

Pharmacologist & Toxicologist CTE Introduction. What is a Pharmacologist? Develop new drugs to cure, treat, and prevent disease. Develop new drugs to.

Class of 2013 Fellows May 20, 2013 Sheraton Boston Hotel Boston, MA USA.

Physiologists & the FDA Kevin J. Greenlees, Ph.D., DABT Senior Advisor for Science & Policy Office of New Animal Drug Evaluation FDA Center for Veterinary.

A-38 Table 5.1: Total Number of Active Physicians (1) per 1,000 Persons by State, 2010 and 2011 Source: National Center for Health Statistics. (2014).

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

The Interagency Food Safety Analytics Collaboration: Moving Forward Together Christopher Braden, MD Director, Division of Foodborne, Waterborne, and Environmental.

JOINT ADVISORY COMMITTEE ON COMMUNICATIONS CAPABILITIES OF EMERGENCY MEDICAL AND PUBLIC HEALTH CARE FACILITIES Structure for Advisory Committee.

Relating Food Animal and Human Antimicrobial Use Comments to the FDA Anti-Infective Drugs Advisory Committee on behalf of the on behalf of the American.

1 Overview: The Federation of State Beef Councils.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

FDA Science Board Drug Safety Initiative April 15, 2005 Rockville, MD RADM Steven Galson, MD, MPH Acting Director, Center for Drug Evaluation and Research.

Needs and Recommendations for the United States Poliovirus Vaccine Stockpile Report of the Joint Working Group of the National Vaccine Advisory Committee.

“History is a set of lies agreed upon.” Napoleon Bonaparte.

FDA’s Draft LDT Framework & Personalized Medicine Update

Drug Transfer Into Breast Milk and Interpretation of Data Lawrence J. Lesko Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation.

HESI ILSI Health and Environmental Sciences Institute HESI PROJECT COMMITTEE ON DOSE-DEPENDENT TRANSITIONS IN MECHANISMS OF TOXICITY NANCY G. DOERRER,

CI-1 Zelnorm ® (tegaserod maleate) Gastrointestinal Drugs Advisory Committee Meeting July 14, 2004 Gastrointestinal Drugs Advisory Committee Meeting July.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Margaret Khaitsa College of Veterinary Medicine Mississippi State University.

Saftey Agencies in Healthcare Practice OSHA CDCP CLIA FDA ISO WHO NIH USDHHS.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Research Animal Welfare & Scientific Integrity: An AAALAC International Perspective John F. Bradfield, DVM, PhD, DACLAM Senior Director, AAALAC International.

CI-1 ATACAND ® (candesartan cilexetil) Cardiovascular and Renal Drugs Advisory Committee Rockville, Maryland February 24, 2005 C.

Nanotechnology - USDA - 18 Nov 2002 REGULATORY CONSIDERATIONS FOR NANOTECHNOLOGY IN PUBLIC HEALTH FOOD AND DRUG ADMINISTRATION Norris E. Alderson, Ph.D.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Research in the Office of Vaccines Research and Review: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation and Research.

Tuskegee Institute’s Role in the Diversification of Veterinary Medicine BY Alex Edwards.

1 Drug Safety Oversight Board: Recent Activities FDA Science Board Advisory Committee Meeting March 31 st, 2006 Douglas C. Throckmorton, MD Deputy Director.

FDA ADVISORY COMMITTEES Mary A Foulkes, Ph.D. Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research, FDA FDA/Industry.

The Regulatory Science of Regenerative Medicine Celia M. Witten, Ph.D., M.D., Director Office of Cellular, Tissue and Gene Therapies Center for Biologics.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Harold I Perl, PhD Center for the Clinical Trials Network National Institute on Drug Abuse 8 th Conference of INEBRIA Boston, MA September 23, 2011.

The CDRH Software Message (October 19, 2002) John F Murray Jr.. Center for Devices & Radiological Health US Food and Drug Administration

David M. Deci, M.D. Director Office of Medical Student Education Associate Professor, Department of Family Medicine University of Wisconsin School of Medicine.

The Benefits of VICH to VICH Member Countries and Regions DONALD A. PRATER, DVM Director, U.S. FDA Europe Office Office of International Programs Office.

David E. Schneider, Ph.D. President, Michigan Association of Higher Education/MEA-NEA Professor of Communication at Saginaw Valley State University Salaries.

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 1 Advisory.

Managing a Laboratory Sponsored by: ASPET's Women in Pharmacology Committee APS Women in Physiology Committee Monday 4 April 2005.

Update: NIFA’s Farm Bill Implementation

Physicians per 1,000 Persons

FDA Perspective on Cardiovascular Device Development

How Available is Health Care?

Anesthesiology Grand Rounds & Journal Club Denham S. Ward, MD, PhD

“Controversies in the prevention of mother-to-child transmission in

Professional Organizations

How Can I Get More Information on VICH?

From Innovation to Commercialization Access to Data

Establishing a career in Nutrition and Endocrinology

Presentation transcript:

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

Welcome to VMAC Comments by Dr. Stephen F. Sundlof, D.V.M., Ph.D. Director Center for Veterinary Medicine October 13, 2004 Rockville, Maryland

Purpose of Meeting First macrolide under Guidance for Industry #152  Pfizer Animal Health application for use of tulathromycin in cattle, swine CVM reviewed microbial safety information Asking VMAC for input on assessment

Committee Members Arthur L. Craigmill, Ph.D., University of California Sherman (Skip) W. Jack, D.V.M., Ph.D., College of Veterinary Medicine, Mississippi State

Committee Members John J. McGlone, Ph.D., Texas Tech University and Health Sciences Center Lisa Nolan, D.V.M., Ph.D., Iowa State University Mark G. Papich, D.V.M., College of Veterinary Medicine, North Carolina State University

Retiring Committee Members VMAC Chair, John T. Waddell, D.V.M., Sutton Veterinary Clinic, P.C., Sutton, Nebraska Marguerite Pappaioanou, D.V.M.,Ph.D., Office of Global Health, Centers for Disease Control and Prevention Dennis P. Wages, D.V.M., North Carolina State University, College of Veterinary Medicine

Consultants, Future Committee Members Susanne Aref, Ph.D., Department of Statistics, Virginia Polytechnic Institute and State University Gregory Jaffe, Center for Science in the Public Interest

Consultants, Future Committee Members Katrina L. Mealey, D.V.M., Ph.D., Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University Richard A. Sams, Ph.D., Ohio State University, Analytical Toxicology Laboratory, Ohio State University Veterinary Hospital

Supplemental Expertise James E. Leggett, Jr., M.D., Chair of CDER’s Anti-Infective Drugs Advisory Committee, Oregon Health Sciences University

AIDAC Consultants Nathan Thielman, M.D., Duke University Medical Center Christopher Ohl, M.D., Wake Forrest University L. Barth Reller, M.D., D.T.M.&H., Duke University Medical Center

Additional Experts John Powers, M.D. Mike Apley, D.V.M.,

Historic Meeting Drug under review is a macrolide, a Category I drug, thus eligible for VMAC review under Guidance for Industry #152 Qualitative risk assessment of drug Transparent, open public meeting