ARTICLE | Regulation
It will take time for sponsors to develop use cases for the new pathway
By Steve Usdin, Washington Editor
June 7, 2024 9:29 PM UTC
The concept animating FDA’s new platform technology designation is simple; executing it won’t be as easy. The idea is to create a predictable pathway for drug manufacturers to leverage and reuse technologies for multiple products. Allowing manufacturers and regulators to focus on what is different about a new medicine, rather than generating and reviewing data that are uninformative, can accelerate product development and improve the quality of reviews.
“The overall goal is to try and minimize redundancy and really expedite development,” Nicole Verdun, director of CBER’s Office of Therapeutic Products, said during a discussion of the platform technology designation at the BIO annual meeting. …
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- Source: https://www.biocentury.com/article/652643/fda-taking-broad-approach-to-its-new-platform-technology-designation