The former FDA commissioner, Scott Gottlieb, MD, had envisioned that the Innovation Office at the FDA could leverage an improved understanding of biomarkers to build modalities and to be able to take some of the risks and costs out of drug development.
In his words: “The whole reason for the cost of drug development is high is that the science of prediction is costly and uncertain,” …“We believe the time has come to make the science of drug development a more formal scientific discipline within the new drug approval process, along with the components that it comprises.”
As part of its efforts to increase patient access to medicines by increasing generics competition, the USP released a Generics Access Plan. The plan offers new and revised quality standards, training and education, and collaborates with FDA.
Forthcoming guidance will include a structured application for biosimilars manufacturers to seek designations that their products are interchangeable with original biologics.
Source: FDA creating innovation office to speed drug development | FierceBiotech
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