Drugs

Changes Proposed to Manufacturing Tech Draft

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA efforts to further enhance the adoption of advanced manufacturing technologies (AMTs) in drug manufacturing, including through the implementation of the new AMT designation program. Commenting on an agency draft guidance on the designation program, the association says FDA should:

acknowledge the broad scope of the AMT designation program;
clarify how it will expedite the review of products manufactured using a designated AMT;
revise the guidance to ensure that BLA sponsors may use drug master files to the full extent Congress provided;
elaborate on the distinctions between the AMT designation program and the ETT/CATT programs (CDER’s Emerging Technology Team and CBER’s Advanced Technologies Team); and
remove references to “graduating” technologies and instead provide guidance on how the agency will prioritize and focus resources.

PhRMA offers eight additional points to help clarify the guidance’s recommendations.

In its response, the Duke-Margolis Institute for Health Policy submits an issue brief on advanced manufacturing technologies containing recommendations that it says are pertinent to the draft guidance.

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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