Dr. Hampshire continues to be busy taking on approximately two new clients each month. Requests to assist in the initial animal study design and FDA presubmission process dominate the case load. Investigational Device Exemption preclinical narratives and responses to FDA deficiencies regarding preclinical and biocompatibility outcomes are also frequent requests.
Continued efforts involve study design to minimize overall animal use by leveraging large animal studies to replace rodent biocompatibility endpoints using the same methods, scientific principles, and endpoints from the ISO 10993 series.
An upcoming presentation on GLP requirements for preclinical studies is scheduled for the April 2018 meeting of SOCRA in Miami.