Drugs

Innovative Manufacturing Technologies Comments

The Biotechnology Innovation Organization (BIO) is asking FDA to include more detailed strategic plans, complete with actionable deliverables and specific timelines, in the agency’s draft strategy document on innovative manufacturing technologies. “Specifically,” BIO says, “we recommend that the strategic plan and suggested activities outlined in the document include how FDA will facilitate the use of innovative manufacturing technologies, including addressing potential barriers to their adoption and adding in more specificity and forward-looking direction.”

BIO also says it encourages FDA to include these areas in the document: international collaboration and harmonization, advanced manufacturing technology designation program, and spectrum of advanced manufacturing technologies.

In its comment, Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should identify opportunities to encourage appropriate international harmonization of regulatory standards for advanced manufacturing in various multi-stakeholder forums. “The agency could use these opportunities to advance global harmonization and regulatory predictability,” it says, “thereby mitigating the risk associated with developing novel technologies.”

PhRMA also encourages FDA to periodically share examples of the benefits of using innovative manufacturing, such as how the technology can improve process efficiency or reduce the potential for human error.

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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