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USFDA CMC Guidance: Advanced Manufacturing Technologies Designation Program

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research updated the guidance "Advanced Manufacturing Technologies Designation Program" which improves product quality through higher capability manufacturing designs and enhanced controls.


Advanced manufacturing is a term for an innovative pharmaceutical manufacturing technology or approach that has the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access to quality medicines for the public.


To improve manufacturing reliability and optimize the development time of drug and biological products, FDA encourages the early adoption of advanced manufacturing technologies (AMTs). The technology can help ensure quality and support a robust supply of drugs that are necessary for survival, life-sustaining, of critical importance for providing healthcare, or that are in short supply.


This draft guidance provides recommendations to persons and organizations interested in participating in the FDA's Advanced Manufacturing Technologies Designation Program, which facilitates the development of drugs, including biological products, manufactured using AMTs that have been designated as such under the program.


Specifically, 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 communicate receipt of and provide advice on an AMT designation request.

  • When and how the FDA will assess AMT designation requests.

  • The process by which the FDA will engage with holders of designated AMTs and applicants for drugs manufactured using, referencing, or relying upon a designated AMT.

  • Potential benefits related to drug development and application assessment.


To know more about the AMT Designation requests, the benefits of AMT, etc. click this LINK.



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