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www.fdanews.com/articles/138062-precedent-may-play-small-role-in-oc-drug-device-decisions

Precedent May Play Small Role in OC Drug, Device Decisions

July 5, 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precedent as it mulls requests for designation (RFD) to determine whether products are drugs, devices or biologics, a draft guidance says.
Washington Drug Letter