Drugs

AMT Designation Program Guidance

FDA has published a guidance, Advanced Manufacturing Technologies Designation Program, with recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program. The document says the program facilitates the development of drugs manufactured using an AMT that has been designated as such under the program.

The guidance outlines the eligibility criteria for AMT designation, the submission and assessment process for requests, and the benefits of receiving an AMT designation and includes a questions-and-answers section to cover additional details about key concepts important for program utilization.

Specifically, it says, the guidance describes:

the process for submitting an AMT designation request, including a description of eligibility criteria and the data and other information to be included;
when and how FDA will assess designation requests;
the process by which FDA will engage with requestors, holders of designated AMTs, and applicants for drugs manufactured using, referencing, or relying upon a designated AMT; and
benefits related to drug development and application assessment.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome