The US Food and Drug Administration (FDA) this week issued draft guidance detailing its new advanced manufacturing technologies (AMT) designation program, offering insights on submitting designation requests, agency communications and how the agency will engage with designation holders. FDA said it will expedite the development and assessment of applications and supplements that receive the designation.
The guidance outlines the eligibility criteria, the procedures for submitting designation requests, how FDA will assess designation requests and communicate with sponsors on applications…
