Home » Precedent Means Little in OCP’s Drug, Device Determinations
Precedent Means Little in OCP’s Drug, Device Determinations
The Office of Combination Products (OCP) may give little weight to regulatory precedent as it mulls requests for designation (RFD) to determine whether a product is considered a drug, medical device or biologic, a new draft guidance says.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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