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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In an unusual move, the FDA has backed off deadlines in a recent draft guidance on Coronavirus Aid, Relief and Economic Security (CARES) Act information reporting after the industry lodged several pointed complaints.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
Fort Lauderdale, Fla.-based ECI Pharmaceuticals has received a warning letter from the FDA, which said the generic drugmaker incorrectly listed two hormone products on FDA’s Drug Registration and Listing System (eDRLS), and of misbranding. Read More
Clinical challenges and public health concerns combined to derail an FDA approval for Avenue Therapeutics’ intravenous tramadol for acute pain. Read More
A federal judge has ruled that the government incorrectly threatened AstraZeneca with fines for limiting discounts to the controversial 340B Drug Discount program for safety-net hospitals. Read More