WMIS presents tools for IND approval
Easing FDA investigational new drug (IND) approvals for novel PET probes is the subject of a study recently published in Molecular Imaging and Biology and announced today by parent organization The World Molecular Imaging Society.
A more integrated and cost-effective scenario for achieving IND approvals is presented by researchers from the department of molecular and medical pharmacology at the University of California Los Angeles (UCLA), including Sherly Mosessian, PhD, chief adminitrative officer for the department.
“[UCLA] has utilized in-house resources in its academic setting to establish and implement a path for satisfying FDA regulatory requirements for approval of PET probe INDs in a streamlined and reduced cost approach,” wrote Mosessian et al.
The approach was validated by quick FDA phase I IND approval for three investigational FAC PET agents. The protocol demands a concerted look at five key areas and suggests making improvements where a lack of standardization is found in:
- Preclinical safety pharmacology and toxicology
- Preclinical imaging and dosimetry
- Chemistry, controls and manufacturing
- Clinical study design
- An overall IND submission strategy to satisfy the phase I IND requirements
The strategy was said to be more successful if it is accomplished "in an open and cooperative manner with the FDA," according to the study. It was also said to be essential that academic sites have some sort of protocol for the translation of PET imaging probes from preclinical research to clinical investigations lest new discoveries stall in the preclinical phase.