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FDA Clarifies Scope Of Its Emerging Technology Program

 
• By Joanne S. Eglovitch

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.

Batch versus continuous manufacturing

FDA’s final guidance on a program for encouraging the use of continuous manufacturing and other new pharmaceutical technologies clarifies the types of emerging technologies that are eligible for review under the agency's Emerging Technology Program.

The guidance also permits FDA's Office of Regulatory Affairs and the Office of Compliance in the agency's Center for Drug...

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