FDA Clarifies Scope Of Its Emerging Technology Program
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.
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US FDA Program Adds Staff, Graduation Concept To Help Advance Newer Manufacturing Technologies
Agency will expand staffing to address requests for help from its Emerging Technology Program, while “graduating” technologies with which it gains sufficient experience.
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.
Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning
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