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portada Animal Drug User Fee Agreements: Advancing Animal Health for the Public
Type
Physical Book
Author
Publisher
Language
English
Pages
36
Format
Paperback
Dimensions
27.9 x 21.6 x 0.2 cm
Weight
0.11 kg.
ISBN13
9781507589441
Categories

Animal Drug User Fee Agreements: Advancing Animal Health for the Public

Education Labor a. Committee on Health (Author) · Createspace · Paperback

Animal Drug User Fee Agreements: Advancing Animal Health for the Public - Committee on Health, Education Labor a.

New Book Imported to South Africa
Delivery: 15 Sep - 28 Sep Shipping: 16 to 20 business days.
R 434
R 434

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Synopsis "Animal Drug User Fee Agreements: Advancing Animal Health for the Public"

We have convened this hearing this morning to examine the animal drug and animal generic drug user fee agreements that are due to be reauthorized this year--the Animal Drug User Fee Agreement, called ADUFA, and the Animal Generic Drug User Fee Agreement, called AGDUFA. These programs mirror the fee programs for human medical products that this committee shepherded through the Senate last Congress as part of the FDA Safety and Innovation Act. Both ADUFA and AGDUFA allow FDA to collect user fees from sponsors of animal drug and animal generic drug applications, and the Agency uses those fees to help fund the review of animal drug applications. At today's hearing, we will discuss the history and purpose of these agreements between FDA and the animal drug industries that it regulates. We will delve into the agreements themselves to better understand the revenue that the fees provide and the performance standards that will benefit the industries paying those fees.

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