As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate ...
PHILADELPHIA & LONDON, September 03, 2025--(BUSINESS WIRE)--Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, today announced that the IRO® platform has received Advanced ...
Industry is welcoming of the US Food and Drug Administration's (FDA) upcoming advanced manufacturing technologies (AMT) program but is clamoring for more clarity on crucial details like what methods ...
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors interested in participating in the Advanced Manufacturing Technology (AMT) designation program. In response to ...