Final statutory language enacted 29 December outlines how the US Food and Drug Administration must consider requests to designate platform technologies like nucleic acid sequences and viral vectors for expedited development and review of new drugs and biologics.
How US FDA Must Designate Manufacturing Platforms To Help Speed Approvals
Initial product approvals will kick off a process that an FY23 spending bill provision establishes for the pharmaceutical industry to build on prior knowledge from manufacturing platform technologies. But the FDA can only designate platforms that really will expedite the development and review of new drugs and biologics.
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