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FDA warns of “important” clinical trial protocol deviations
The U.S. Food and Drug Administration (FDA ... protocol-specified procedures that occur without prior IRB approval and submission to FDA of a protocol amendment to implement the modification ...
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60 Degrees Pharmaceuticals obtains IRB approval for chronic babesiosis therapy trial
US-based pharmaceutical company 60 Degrees Pharmaceuticals has received approval from the investigational review board (IRB) ...
60 Degrees says FDA does not object to tafenoquine import plan
Degrees Pharmaceuticals (SXTP) announced that the United States Food and Drug Administration does not object to the company’s plan to import ...
INmune Bio announces plans to submit FDA BLA for CORDStrom
INmune Bio (INMB) announced, following a Type C meeting with the U.S. Food and Drug Administration, FDA, its intent to submit a Biologics ...