View Rule

The Minor Use and Minor Species Animal Health Act of 2004 established new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species, as well as uncommon diseases in major animal species. FDA has the authority to provide for animal drug conditional approval after all safety and manufacturing components of a new animal drug approval have been met. For the effectiveness component of  a new animal drug review, a reasonable expectation of effectiveness must be established prior to conditional approval. Sponsors then have up to five years to complete full effectiveness and achieve a complete new animal drug approval.