FDA crackdown on U Penn
WASHINGTON - The University of Pennsylvania said the FDA has temporarily suspended all gene therapy research at the university's Institute for Human Gene Therapy (IHGT) as a result of alleged violations of safety regulations uncovered during an investigation of the widely publicized death of Jessie Gelsinger, a gene therapy patient, in September.
The FDA investigation apparently has produced new revelations about procedural improprieties on the part of university investigators. According to the university, the FDA asserted in a letter on Friday that IGHT failed to complete paperwork formally enrolling patients in the trial in which Gelsinger died, and that they allegedly wrote up and filed undated eligibility forms after the death.
The university said the agency also is alleging that