This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.
Why Should You Attend:
The rapid development of cell-based and related biological therapies for use in veterinary medicine has provided exciting new options for the safe and effective treatment of common veterinary diseases and conditions such as osteoarthritis, tendon strain injuries, suspensory desmitis, congestive heart failure and other commonly diagnosed diseases and injuries.
FDA’s Center for Veterinary Medicine (“CVM”) asserts primary and exclusive regulatory jurisdiction over veterinary regenerative products and their future commercialization in the U.S. Under CVM’s proposed regulatory approach, a veterinary regenerative product exceeding a hypothetical veterinary equivalent standard will be treated as a drug requiring FDA review and approval prior to marketing and sale.
Added by complianceonlinecom on June 1, 2012