US Gov signs authorisation of animal drug laws
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 authorise 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 authorising 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.
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