FDA regulatory

Chemical structure (CS)

Definition

A pharmacologic class describing the drug's chemical family.

Suffixed [CS]. Relevant to cross-sensitivity questions, such as identifying every cephalosporin in a formulary.

Established Pharmacologic Class (EPC)The FDA-assigned class that appears in a drug's label as its scientifically valid pharmacologic classification.Definition

More in FDA regulatory

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

All 153 terms Coding guide J-code directory