FDA Publishes Adequate And Well-Controlled Studies Final Rule

In the March 5, 1998, Federal Register, FDA published a final regulation further defining "adequate and well-controlled studies." The purpose of this final rule is to further define "adequate and well-controlled" to require that field investigations be designed and conducted in a scientifically sound manner, taking into account practical conditions in the field and differences between field conditions and laboratory conditions. The rule implements, in part, the Animal Drug Availability Act of 1996, which amended the Federal Food, Drug, and Cosmetic Act to enable more efficient approval and more expeditious marketing of safe and effective animal drugs. The regulation went into effect on April 6, 1998.

The Federal Register notice for this final rule is available for review or downloading on CVM's Internet Website at http://www.cvm.fda.gov. Paper copies are available from the Communications Staff, FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, Md. 20855, telephone 301/594-1755.

Questions about this rule may be directed to Herman M. Schoenemann, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Place, Rockville, Md. 20855, 301/594-1638.

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