FDA releases guidance for generic applications

In draft guidance released Friday, FDA clarified the use of reference standards for bioequivalency studies in generic drug applications. The guidance said FDA will take measures to speed review of generic applications and ensure availability of reference standards.

The document clarified the definitions of reference standards and reference listed drugs. It specified that the reference standard is the compound selected by FDA that must be used in bioequivalency studies, while the reference listed drug is the previously approved drug that the generic duplicates. FDA said the two are ordinarily the same, but may not be in cases where the listed drug is no longer marketed...