Unpacking FDA’s long-awaited platform technology designation program and guidance

BY RACHEL COE, MSC

Months overdue, the FDA’s Platform Technologies Designation guidance document has just been published by the agency. AgencyIQ breaks down what the designation means for sponsors and its limits for product sponsors.

As part of the 2023 Consolidated Appropriations Act (Section 2503), Congress directed FDA to establish a new “Platform Technologies Designation” program.

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