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A decision on the composition of a COVID-19 vaccine to be administered to the American population beginning this fall will need to be made by June. Read More
In a study with 1,854 participants, 50 mg of Quviviq led to significant improvements in sleep onset, sleep maintenance and self-reported total sleep time. Read More
The FDA has turned down a citizen petition seeking that the investigators and the institutional review board (IRB) at Minneapolis, Minn.-based Hennepin County Medical Center (HCMC) be barred from conducting clinical trials. Read More
In 2021, the FDA’s Center for Drug Evaluation and Research (CDER) issued fewer warning letters but conducted moregood clinical practice inspections that the previous year, according to the annual report from CDER’s Office of Compliance (OCC). Read More
The approval was supported by positive data from two pivotal studies in which patients showed significant improvement in the disease over those who received a placebo. Read More
The FDA has released four related final guidances to help drugmakers submit electronic safety reports — including advice on how to conform to the latest International Council for Harmonization (ICH) standard. Read More