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Researchers planning trials on the use of convalescent blood plasma to treat COVID-19 must submit an investigational new drug (IND) application, according to a new FDA final guidance that will remain in effect only for the duration of the public health emergency. Read More
Rep. Diana DeGette (D-Colo.) has called on the FDA to ensure that supplies of hydroxychloroquine and chloroquine are saved for approved indications, citing reports of hoarding. Read More
The FDA cited sterile drugmaker Nanobots Healthcare in Houston, Texas in a lengthy Form 483 for deficiencies with testing, sterility, certification and equipment calibration. Read More