The US House Committee on Appropriation approved a $3.212 billion budget for the 2021 fiscal year. Part of the funding bill also gives the Food and Drug Administration authority to recall unsafe prescription and over-the-counter drugs. The proposed budget also...
The FDA released the app FDA MyStudies, which can be found in app stores as COVID MyStudies, for patients to provide informed consent for traditional clinical trials, real-world trials, observational studies, and registries. The app is free, as...
The FDA announced on Wednesday (5/27) new guidelines via a Q&A format for how Covid is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video conference....
In their business update, Moderna announced they received FDA clearance to move into Phase 2 of their study for the COVID-19 vaccine. In their press release, they also reported additional funding from Biomedical Advanced Research and Development Authority (BARDA) as...
The FDA announced that it would strengthen its oversight for companies marketing the Covid serology tests. After questions came to light in regards to the accuracy of some of the testing kits, the FDA is now requiring commercial manufacturers to submit an emergency...
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