Regulatory Considerations for Using Pharmaceutical Products in Research Involving Laboratory Animals

Audience: The program is tailored to IACUC staff, IACUC members, IOs, veterinarians, investigators, compliance personnel, animal care staff and others involved in animal programs.

Speakers:

• Dorothy Bailey, DVM, Program Head, Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Center for Veterinary Medicine, FDA
• Neal Bataller, ME, DVM, Division of Surveillance, Center for Veterinary Medicine, FDA

Topics: Dr. Bailey discusses the legal options for use of drugs in laboratory research animals. These include new animal drug approval, conditional approval, investigational use, and indexing. Dr. Bataller discusses the regulatory status of drugs, including the extralabel use of approved drugs, compounding from bulk drugs, and other illegal manufacturing.