CVM Small Business Assistance
Most of the Center for Veterinary Medicine’s (CVM) public--the firms affected by its regulations—are, by definition, small businesses. A small business is one that has fewer than 500 employees, including employees of affiliates. The purpose of CVM’s outreach to small businesses is to provide information and guidance regarding the regulations and requirements for obtaining approval to manufacture, market and distribute animal products regulated by CVM.
The Center for Veterinary Medicine regulates the manufacture and distribution of food additives, drugs and devices given to, or used on, pets, and animals from which human foods are derived. These animals include more than one billion companion animals, plus billions of poultry, cattle, swine, and minor animal species. (Minor animal species are animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)
The following links provide CVM information related to questions frequently asked by small businesses:
- The Journey of an Animal Drug through the Approval Process
- New Animal Drug Applications
- Guidance for Industry regarding New Animal Drug Applications
- Animal Drug User Fee Act (ADUFA)
- Generic Animal Drug Approval Process
- Animal Generic Drug User Fee Act (AGDUFA)
- Guidance for Industry regarding User Fees
- Minor Use/Minor Species (MUMS)
- Guidance for Industry regarding Minor Use/Minor Species
Contact CVM
240-402-7002
[email protected]
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-1
Rockville, MD 20855
CVM Ombudsman
[email protected]