Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

Activity

Animal Health Institute filed 1 comment on this docket between Dec 15, 2015 and Dec 15, 2015. 1 other organizations filed here. The comment window closed 7160d ago.

What Animal Health Institute filed (1)

Abstract

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize the U.S . Food and Drug Administration (FDA, the agency) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species . At this time, FDA is issuing proposed regulations to implement section 572 of the act entitled "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species ." These regulations propose administrative procedures and criteria for index listing a new animal drug for use in a minor species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species .

• Animal Health InstituteTHIS ORG

  1 filing · confidence 97%
• American Veterinary Medical Associationtrade assoc.

  3 filings · confidence 97%