ABSTRACT
In the United States, the FDA approves and grants marketing authorization of generic drugs by applying the regulatory requirements provided in the Code of Federal Regulations (CFR) (Table 14.1).
A generic drug is bioequivalent to the listed drug if “the rate and extent of the absorption of the drug do not show a signicant difference from the rate and extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses” (21 U.S.C. 355(j)(8)(B)(i)).
