Table of Contents

Regulatory Research
Regulatory Review
Student Summer Intern
How to Apply

CVM is a public health organization that enables the marketing of effective animal drugs, food additives, feed ingredients, and animal devices that are safe to animals while ensuring that edible products from treated animals are safe to humans and the environment. The Center performs research, monitors product safety and efficacy, and continually strives to improve the quality of its processes.

REGULATORY RESEARCH ACTIVITIES

The Center's regulatory mission is supported by a comprehensive science-based research program that is housed in a state-of-the-art research facility that was dedicated in 1996. It also has an extramural research component which compliments its intramural program by expanding the Center's research capability through contract research. All Center research is conducted to investigate basic problems related to the Center's regulated products. Modeling of concepts that may enhance the review of unapproved and approved drugs, food additives and devices is the focus of basic animal research at the Center. Assay methodology development and validation are major research activities of the Office of Research. Methodology research has focused on drug residues in meat, milk, honey, and eggs. Both "spiked" and incurred residues are evaluated in the residue models.

Pharmacology of Drug Action

Researchers evaluate the comparative pharmacokinetics of drug metabolism and distribution in appropriate target animal models. Maturational, nutritional, and disease related factors affecting drug metabolism are also evaluated. Drug Residue Methodology Researchers develop and validate methods to determine the quantity of drug residues present in edible animal tissue, body fluids, milk, eggs and feeds. State-of-the-art analytical equipment is available.

REGULATORY REVIEW ACTIVITIES

The primary responsibility of the Center is to review the safety and efficacy of new animal drugs, food additives and marketed animal devices. Thus most of its resources are devoted to product review. The major review areas of the Center are:

Veterinary Medical Review

Veterinary medical officers conduct technical reviews of data in support of the effectiveness of therapeutic drug approvals and make decisions whether or not to approve based the data submitted in support of the request, professional experience, and medical judgment.

Animal Science Review

Animal scientists conduct technical reviews of data in support of the effectiveness and animal safety of production drug (non-therapeutic) approval and make decisions whether or not to approve based on the data submitted in support of the request.

Residue Toxicology Review

Toxicologists conduct technical reviews of the data submitted to support the safety of residues of drugs to both humans and the environment.

Residue Methodology Chemistry Review

Residue chemists review the data submitted to support the absence of harmful residues in edible tissues (meat, milk or eggs) intended for human consumption.

Manufacturing Chemistry Review

Chemists review manufacturing information submitted by the sponsor to support its ability to appropriately manufacture and label an approved new animal drug.

Biometrics Review

Mathematical statisticians review protocols and data submitted by the sponsor to ascertain the validity of the statistical methods proposed by the sponsor. When statistical inferences are made it is important that the population for which the data are intended are appropriately included.

Post Approval Evaluations

Veterinary medical officers, consumer safety officers, chemists, and pharmacologists review the drug experience reports submitted by sponsors and determine the need for no action, label modification or recall.

CVM STUDENT SUMMER INTERN PROGRAM

The FDA's Center for Veterinary Medicine provides training opportunities for undergraduate, graduate and professional students. The program seeks to promote personal development and professional skills reflective of the students' field of study. The ultimate goal is to stimulate an interest in pursuing careers significant to the Center.

Program Goals and Objectives

The CVM Student Intern Program allows the student an educational opportunity, expands career options, and nurtures professionalism and individualized development. The CVM Research/ Review Scientist benefits from hosting an intern by completion of a special research project and promoting consideration of future employment at CVM.

Student Intern Research Plan and Evaluation Plan

Each participating CVM Research/Review Scientist is asked to provide a Student Intern Project that includes a plan that states the objectives and a critical evaluation plan to be conducted at four-week intervals. It is recommended that the CVM Research/Review Scientist or a designee meet with the student on a weekly basis to best provide the mid-term and final evaluations.

Program Collaboration

This program is conducted in collaboration with the National Institutes of Health, Minority Access to Research Careers (MARC) Program, the National Science Foundation, and Alliances for Minority Participation (AMP). The Program is administered by CVM’s Office of the Center Director.

Applying to the CVM Student Intern Summer Program:

If you are interested in doing research at CVM, you may download a copy of the application from the 2008 Summer Intern (SI) Program "Windows to Regulatory Research" page.

For further information or help with the application process, contact:

Dr. Marcia K. Larkins
Coordinator, Summer Intern Program
Food and Drug Administration
Center for Veterinary Medicine
7519 Standish Place, HFV-3
Rockville, Maryland 20855
Office 240-276-9015 FAX 240-276-9060
Email - marcia.larkins@fda.hhs.gov

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