FDA regulatory

Mechanism of action (MoA)

Definition

A pharmacologic class describing the molecular target through which a drug acts.

Appears in FDA data suffixed with [MoA]. A single drug commonly carries several MoA classes alongside one EPC.

Established Pharmacologic Class (EPC)The FDA-assigned class that appears in a drug's label as its scientifically valid pharmacologic classification.Definition Physiologic effect (PE)A pharmacologic class describing the observable bodily effect a drug produces.Definition

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505(b)(2)AB rating Abbreviated New Drug Application (ANDA)Active ingredient Active moiety Biologics License Application (BLA)Biosimilar Boxed warning

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