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The FDA has announced that it found four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the troubled Emergent BioSolutions manufacturing facility in Baltimore, Md., to be acceptable for use for potential export. Read More
Newly confirmed and sworn-in FDA Commissioner Robert Califf spelled out some of his priorities in a Feb. 17 memo to the agency’s staff and repeated them in a series of tweets from his brand-new Twitter account — @DrCaliff_FDA. Read More
Collins and Nelson will help oversee the creation of the Advanced Research Projects Agency for Health, which will research treatments for serious ailments, including cancers, infectious diseases and Alzheimer’s disease. Read More
In an unusual move, the FDA has backed off deadlines in a recent draft guidance on Coronavirus Aid, Relief and Economic Security (CARES) Act information reporting after the industry lodged several pointed complaints. Read More