The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic difluprednate emulsion, entitled ``Draft Guidance on Difluprednate.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for difluprednate emulsion.
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Bioequivalence Recommendations for Difluprednate; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic difluprednate emulsion, entitled ``D...
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82 FR 10775
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“Bioequivalence Recommendations for Difluprednate; Revised Draft Guidance for Industry; Availability,” thefederalregister.org (February 15, 2017), https://thefederalregister.org/documents/2017-02972/bioequivalence-recommendations-for-difluprednate-revised-draft-guidance-for-industry-availability.