Posted: 08 Aug 2016 06:55 PM PDT By Jay W. Cormier – As readers of this blog may recall, FDA observed remarkable conditions at two facilities on the NIH campus in Bethesda, MD (see our post here). Then, earlier this year, NIH stated again that it was closing its drug manufacturing facilities (see our posthere). What wasn’t clear in April was whether the facility closures were the same facilities as were the subject of the 2015 inspection. A newly released letter from FDA to NIH, however, confirms that the facilities were, in fact, the same facilities. In that letter from FDA, dated July 29, 2016, FDA provides a number of new details regarding the ongoing manufacturing issues at NIH. Specifically, we learn that:
We will continue to monitor NIH’s remediation efforts. |
martes, 9 de agosto de 2016
FDA Law Blog: NIH Intends to Open New Manufacturing Facility by End of October
FDA Law Blog: NIH Intends to Open New Manufacturing Facility by End of October
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