Introduction and Overview
View Presentation *David M Petullo, Center for Veterinary Medicine Keywords: Center for Veterinary Medicine, study design, sample size, power, safety, effectiveness FDA’s Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. Within CVM, The Office of New Animal Drug Evaluation (ONADE) determines whether or not a “new animal drug” should be approved. Section 512 of the Federal Food, Drug, and Cosmetic Act (FFDCA) was designed to ensure that animal drugs are safe and effective for their intended uses. If the product is for use in a food-producing animal, human food safety studies must also be conducted to determine withdrawal times that will ensure that the edible animal products are free of unsafe drug residues. Studies to demonstrate effectiveness and safety at CVM employ many different experimental designs and analyses to incorporate features relevant to each particular species and its associated husbandry practices in addition to features related to the variety of indications for both companion and food producing animals.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC