August 18, 2008
President Bush Signs Reauthorization of User Fees for Pioneer Animal Drugs and Authorization of the First Ever User Fee Program for Generic Animal Drugs
On August 14, 2008, President Bush signed the Animal Drug User Fee Amendments of 2008 (ADUFA). ADUFA was originally passed in 2003 and was set to expire on September 30, 2008. The new amendments extend ADUFA until 2013. ADUFA amends the Food, Drug and Cosmetic Act to authorize FDA to collect fees to enhance the performance of the new animal drug review process and ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.
President Bush also signed into law the Animal Generic Drug User Fee Act (AGDUFA) of 2008. This Act amends the Food, Drug and Cosmetic Act by authorizing the first ever generic animal drug user fee program. These fees will enhance the performance of the generic new animal drug review process and will enable FDA to better ensure that generic new animal drug products are safe and effective and give consumers a lower cost alternative to pioneer drugs.
Animal Drug User Fee Amendments of 2008
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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