Home » Guidance: Precedent May Hold Little Weight for OC’s Drug, Device Determinations
Guidance: Precedent May Hold Little Weight for OC’s Drug, Device Determinations
June 21, 2011
The Office of Combination Products (OC) may give little weight to regulatory precedent as it mulls requests for designation (RFD) to determine whether products are drugs, devices or biologics, a draft guidance says.
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