Industry is welcoming FDA’s upcoming advanced manufacturing technologies (AMT) program but is clamoring for more clarity on crucial details like what methods will be covered, which sponsors can take part, and how fast it would work.
The AMT program will foster and expedite the development of manufacturing methods that incorporate a novel technology or use an established technology in a unique way to produce a drug of equivalent or superior drug quality. FDA is required to create the program as part of Congress’ omnibus spending bill in December 2022. (RELATED: Omnibus brings new advanced manufacturing programs to FDA, Regulatory Focus 11 January 2023)
At the end of 2023, FDA outlined plans for the program, including application processes and communications, noting expectations for better quality, shorter development times, and more plentiful supply in draft guidance. The comment period for the guidance closed March 13, following a 30-day extension requested by some stakeholders. (RELATED: FDA guidance details new advanced manufacturing technology designation program, Regulatory Focus 14 December 2023)…
