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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Guidance for Industry, ANDA's: Blend Uniformity Analysis |
| Origin/Publisher: | Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20856, Tel. 301 827 4570, http://www.fda.gov/cder/guidance/index.htm |
| Content: | This FDA guideline provides recommendations as to what data has to be submitted in case of the marketing authorization of abbreviated new drug applications as regards the homogeneity of mixtures and what in-process acceptance criteria are acceptable for blend uniformity analysis. |
| Status: | Draft |
| Document Type: | FDA Guidance for Industry |
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