US FDA to offer series of guidances on regenerative product development – and declares gene therapies eligible for RMAT – as enforcement against 'unscrupulous actors' continues.
US FDA is vowing a crackdown on "unscrupulous actors" in the regenerative medicine industry as part of a policy that could also benefit honest manufacturers.
Coming on the heels of a series of recent enforcement actions against stem cell centers in Florida and California, agency...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
