Storage regulation of bioequivalence test data in controversy

A lawmaker recently claimed the current notice of the Korea Food and Drug Administration (KFDA) on the storage of bioequivalence test data might be a culprit associated with the generic drug's efficacy fabrication.

The allegation came as Rep Moon hee of the National Assembly's Health and Welfare Committee said the KFDA Notice No. 2005-31 of bioequivalence testing (storage for data and specim...