Tag: IND

6
Apr

FDA Approved an IND for Zika Virus

U.S. Food and Drug Administration An IND Approved for Zika Virus The US FDA recently approved an investigational new drug application (IND)* for a test to screen blood donations for Zika virus.  The test is manufactured by Roche Molecular Systems, Inc. (Roche). *: The IND regulations 21 CFR Part 312 (downloadable in PDF here) provides procedures and requirements governing the use of

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16
Feb

Comprehensive Set of Data for FDA IND Trends on Stem Cells

Comprehensive Set of Data for FDA IND Trends on Stem Cells By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 24, 2014   For the first time, a comprehensive set of trended FDA IND data on stem cells is available. The authors have analyzed and compiled “product/CMC, preclinical and clinical information” based on the 66 MSC*-based product

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