Authorisation of Clinical Trials in the US

The US regulates animal trials mainly through the requirement to inform the authorities before non-approved veterinary pharmaceuticals are shipped to trial sites. Depending on whether it is classified as a drug or a biologic, information must be submitted to either the FDA Center for Veterinary Medicines (CVM) or the United States Department of Agriculture (USDA) Center for Veterinary Biologies (CVB). 

Caution. Contains a new animal drug for use only in investigational animals in clinical trials. Not for use in humans. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Pood and Drug Administration or by the U.S. Department of Agriculture. 

If intended for food-producing animals, the labels should also bear the statement  

No official withdrawal time has been established for this product under the proposed investigational use. 

Produce from trial animals may not enter the food chain unless authorised by the CVM on the basis of data showing that residues will be either safe or not present in produce from animals treated at the maximum dosage with the minimum allowed withdrawal period. The CVM must be notified of the date and place of slaughter at least 10 days prior to each shipment for slaughter. The regulations also address the retention of records and the competence of study investigators. Records of drug shipments must be maintained for at least 2 years after the date of shipment. Data and results of trials must be retained for either 2 years after completion of the trial, or 

---