Question: A document submitted to the FDA asking it to make a decision on which agency will take the lead in regulating a combination product is

A document submitted to the FDA asking it to make a decision on
which agency will take the lead in regulating a combination
product is referred to as a:
Biologics License Application (BLA)
Form 510(k)
No answer text provided.
Request for Designation (RFD)
Investigational Device Exemption (IDE)
A document submitted to the FDA asking it to make a

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