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- Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Guidance for Industry (PDF - 171KB)
Posted: 9/6/2017 - Statistical Review - T.R.U.E. TEST (PDF - 527KB)
Posted: 9/6/2017 - Clinical Review - T.R.U.E. TEST (PDF - 435KB)
Posted: 9/6/2017 - New Recommendations to Increase the Dose of GamaSTAN S/D (Immune Globulin [Human]) When Used for Prophylaxis for Hepatitis A
Posted: 9/6/2017
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