2023-27309: Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Public comment closed .
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Advanced Manufacturing Technologies Designation Program." FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products. These technologies can be integral to ensuring quality and supporting a robust supply of drugs that are life-supporting, life-sustaining, of critical importance to providing healthcare, or in shortage. AMTs can directly improve product quality through higher capability manufacturing designs and enhanced controls (e.g., leading to fewer human errors). This draft guidance provides recommendations to persons and organizations interested in participating in FDA's Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program.
The agency’s own summary, as published.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →