1. Mrs. Brandi Robinson Office of New Animal Drug Evaluation Center for Veterinary Medicine Regulating Animal Drugs

2. Protect the Public Health by ensuring Protect the Public Health by ensuring safe and effective animal drugs reach the market safe and effective animal drugs reach the market unsafe and ineffective animal drugs do not reach the market unsafe and ineffective animal drugs do not reach the market Regulating Animal Drugs

3. Animal drugs are articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in animals and articles intended to affect the structure or any function of the body of the animal Animal drugs are articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in animals and articles intended to affect the structure or any function of the body of the animal Defining Animal Drugs

4. The product is safe and effective for its intended use. The product is safe and effective for its intended use. The methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity. The methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity. Approved Animal Drug Approved Animal Drug

5. Human Food Safety Human Food Safety Toxicology Toxicology Residue Chemistry Residue Chemistry Microbial Food Safety Microbial Food Safety Target Animal Safety Target Animal Safety Effectiveness Effectiveness Manufacturing Chemistry Manufacturing Chemistry Environmental Impact Environmental Impact Labeling Labeling All Other Information All Other Information Areas of Review Areas of Review

6. Example: Based on substantial evidence consisting of one or more adequate and well- controlled investigations such as – Example: Based on substantial evidence consisting of one or more adequate and well- controlled investigations such as – a study in a target species a study in a target species a study in laboratory animals a study in laboratory animals any field investigation any field investigation a bioequivalence study a bioequivalence study an in vitro study an in vitro study Defining EffectivenessDefining Effectiveness

7. Example: Adequate tests by all methods reasonably applicable show that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling. Example: Adequate tests by all methods reasonably applicable show that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling. Defining Safety Defining Safety

8. Safety may include: Target Animal Safety Target Animal Safety Human Food Safety Human Food Safety Environmental Impact Environmental Impact User Safety User Safety Safety Safety

9. The cumulative effect of the drug on the animal(s), such that the drug does not adversely affect the treated animal(s) The cumulative effect of the drug on the animal(s), such that the drug does not adversely affect the treated animal(s) Target Animal Safety

10. Toxicology Toxicology Residue Chemistry Residue Chemistry Microbial Food Safety Microbial Food Safety Regulatory Method Regulatory Method Human Food SafetyHuman Food Safety

11. Use, manufacture and disposal does not pose a significant environmental impact Use, manufacture and disposal does not pose a significant environmental impact Environmental Impact

12. Hazards associated with administration to animals Hazards associated with administration to animals Hazards associated with manufacturing Hazards associated with manufacturing Direct - occupational exposure at site Direct - occupational exposure at site Indirect - manufacturing emissions Indirect - manufacturing emissions Hazards associated with use of air, water and solid wastes contaminated via use and disposal of the drug Hazards associated with use of air, water and solid wastes contaminated via use and disposal of the drug User Safety

13. Determines whether an animal drug will have and maintain the necessary quality, strength, purity, and identity Methods and controls Methods and controls Stability data Stability data GMP compliance GMP compliance Manufacturing Chemistry

14. Immediate container (vial, syringe, packet) or feed bag labels Immediate container (vial, syringe, packet) or feed bag labels Package insert Package insert Packaging (box, carton) Packaging (box, carton) Labeling

15. Foreign marketing experience Foreign marketing experience Reports of pilot studies Reports of pilot studies Literature reports Literature reports All Other InformationAll Other Information

16. Pre-submission conference - formal process Pre-submission conference - formal process Sponsor and CVM may discuss and voluntarily agree on Sponsor and CVM may discuss and voluntarily agree on Product Development Plan Product Development Plan General design for each study or use of a standard protocol General design for each study or use of a standard protocol CVM provides guidance documents for various studies CVM provides guidance documents for various studies Simultaneous work under each area of review Simultaneous work under each area of review Example Approval Process: The United States Approach

17. Sponsor conducts studies to generate data following protocol concurrence Sponsor conducts studies to generate data following protocol concurrence Data is evaluated by sponsor and CVM for quality assurance (data integrity) Data is evaluated by sponsor and CVM for quality assurance (data integrity) Data is scientifically reviewed by CVM Data is scientifically reviewed by CVM CVM determines if study is acceptable (pivotal) for making safety or effectiveness decision CVM determines if study is acceptable (pivotal) for making safety or effectiveness decision Example Approval Process: The United States Approach

18. NADA is a systematic approach to document evidence that drug products are safe and effective NADA is a systematic approach to document evidence that drug products are safe and effective Approved drug product consists of the drug, the packaging and the labeling Approved drug product consists of the drug, the packaging and the labeling Example Approval Process: The United States Approach

19. CVM describes the documented evidence in a Freedom of Information Summary, an Environmental Assessment, and in drug labeling. CVM describes the documented evidence in a Freedom of Information Summary, an Environmental Assessment, and in drug labeling. Codifies the approval in the CFR via a Federal Register announcement. Codifies the approval in the CFR via a Federal Register announcement. All are accessible by the public All are accessible by the public Example Approval Process: The United States Approach

20. Protect the Public Health by ensuring Protect the Public Health by ensuring safe and effective new animal drugs reach the market safe and effective new animal drugs reach the market unsafe and ineffective new animal drugs do not reach the market unsafe and ineffective new animal drugs do not reach the market Work efficiently to process and review sponsor submissions and applications Work efficiently to process and review sponsor submissions and applications Work within the limits of statutory authority Work within the limits of statutory authority Example Approval Process: The United States Approach

21. Thank you! Additional Videos on Animal Drug Regulation Available