US FDA ‘Quietly Working Hard’ To Develop Advanced Manufacturing Framework
Soon-to-be-released white papers will FRAME how FDA plans assess products manufactured with advanced technologies as part of an initiative to reduce uncertainty for sponsors.
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US FDA’s Peter Marks, Pfizer’s Mikael Dolsten and other experts discuss what is being done to prepare for the future, worries about higher fatality rates, and what 2023 might look like.
What happens when manufacturing plants are moving targets? When quality systems are at once more centralized and dispersed? When plant operators are health care workers? Agency wants input before settling on the answers.
The White House ‘Biotechnology’ initiative is very broadly focused, with non-health sectors receiving the bulk of the attention. The US FDA’s role is small – but it could further boost attention to efforts to encourage adoption of advanced manufacturing.