Advances In Veterinary Medicine
New law to improve animal drug review President Bush has signed legislation that provides user fees to the FDA for animal drug reviews. Known as the Animal Drug User Fee Act (ADUFA), the law, passed in November 2003, establishes a funding system for the new animal drug review process that is similar to that established for the human drug review process more than a decade ago.
The fees collected for these services will be directed toward the FDA's Center for Veterinary Medicine (CVM) and will be used to provide additional resources for its animal drug review program. The goal is to achieve shorter, more predictable review times by increasing the review staff at CVM and by building better management systems. As a result, the FDA anticipates substantial savings to the industry in regulatory review and developmental expenses without compromising the agency's high standards for safe and effective products.
The FDA is authorized to collect $5 million in fees in fiscal year 2004, which began Oct. 1, 2003; $8 million in fiscal year 2005; and $10 million in fiscal years 2006 through 2008. The law provides for specific waivers or reductions of fees, including for small businesses and where the fees would present a significant barrier to innovation.
"The resources provided by this law will help CVM scientists keep pace with the rapid advances in science and medicine that drive the quality of health care for our animals," says CVM Director Stephen Sundlof, D.V.M., Ph.D. "We view this legislation as a vital component in our commitment to promote and protect public and animal health."
COPYRIGHT 2004 U.S. Government Printing Office
COPYRIGHT 2005 Gale Group
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