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# Draft Guide on Biopharmaceutics Classification System Biowaivers
- URL: https://www.fdaweb.com/draft-guide-on-biopharmaceutics-classification-system-biowaivers/
- Published: 2018-10-26T12:00:00.000Z
- Updated: 2026-09-15T00:40:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142679

*Federal Register* notice: FDA has made available a draft guidance entitled “Biopharmaceutics Classification System-Based Biowaivers” that was prepared by the International Council for Harmonization. The document provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of *in vivo* bioequivalence studies for drug products. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-26/pdf/2018-23425.pdf?ref=fdaweb.com).