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FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis

FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis

The FDA announced on Wednesday (5/27) new guidances via a Q&A format for how COVID-19 is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video...
Moderna Notes Early Signs of Success in COVID-19 Vaccine

Moderna Notes Early Signs of Success in COVID-19 Vaccine

Today (5/18) Moderna announced that its clinical trial in the United States has started to see protective antibodies in data from 8 healthy individuals, chosen at random from a 45-person study. The study, which began in March, and found that the...
Moderna Moves into Phase 2 of COVID-19 Vaccine

Moderna Moves into Phase 2 of COVID-19 Vaccine

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...
FDA Amends Policy for COVID-19 Tests

FDA Amends Policy for COVID-19 Tests

The FDA announced that it would strengthen its oversight for companies marketing the COVID-19 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...