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The FDA spelled out in a new guidance released yesterday how it will conduct formal meetings and deal with new drug applications during the COVID-19 pandemic. Read More
A Seattle-based study of how COVID-19 spreads through the community has put its project on hold at the FDA’s request until it receives an Emergency Use Authorization (EUA) for its lab-developed test and self-swab kit. Read More
Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said yesterday that he still believes a COVID-19 vaccine could be deployed by the end of the year. Read More
Following considerable public outcry over potential conflicts of interest for government officials who are working on the Trump administration’s initiative to develop COVID-19 treatments and vaccines, Janet Woodcock is temporarily stepping down as director of the Center for Drug Evaluation and Research (CDER). Read More
Bangladesh-based Beximco Pharmaceuticals has become the first company to launch a generic version of Gilead Sciences’ remdesivir for treating COVID-19. Read More
The FDA slapped an Aquebogue, New York drug manufacturer with a warning letter over serious data integrity lapses and violations related to environmental and personnel monitoring. Read More