US FDA And NIST Form Partnership To Boost Advanced Manufacturing Techniques
The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.
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US FDA CBER Chief Calls For Industry-Academia Collaboration In Developing Treatments For Ultra-Rare Diseases
The head of the US FDA’s Center for Biologics Evaluation and Research said that new approaches are needed to facilitate product development for ultra-rare diseases. The FDA also announces the creation of a new CBER Advanced Technologies Team to promote the adoption of innovative manufacturing technologies for cell and gene therapy products.
While many in the pharmaceutical sector pay lip service to the digital industrial revolution called 4.0, few have embraced it. But that could be about to change.
FDA has issued final guidance that clarifies the types of technologies eligible for acceptance into the agency's Emerging Technology Program. FDA also issues internal guidance to explain how reviewers should handle emerging technology applications.