Snapshot

The Advanced Manufacturing Technologies Designation Program pathway has been developed by the of United States.

This pathway can be used where Advanced Manufacturing Technologies Designation Program is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program..

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Section 506L(e)(2) of the FD&C Act requires FDA to complete AMT designation determinations regarding designation for a particular context of use and acceptance into the program in writing within 180 calendar days of FDA’s receipt of the request. Submission of an AMT designation request does not guarantee designation or acceptance into the program. FDA expects to deny requests that are incomplete or submitted for methods of manufacturing that do not meet the criteria described in 506L(b) of the FD&C Act.