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 feedback, FDA has revised its guidance to clarify the Advanced Manufacturing Technology (AMT) designation process, the roles of various entities involved in the program, and its application to Biologics License Applications (BLA) applicants to reference an AMT designation within their applications. (RELATED: Industry clamors for clarity on FDA’s advanced manufacturing designation program, Regulatory Focus 21 March 2024)
The guidance finalizes a draft version issued in December 2023. (RELATED: FDA guidance details new advanced manufacturing technology designation program, Regulatory Focus 14 December 2023)…
