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In an unusual move, the FDA has backed off deadlines in a recent draft guidance on Coronavirus Aid, Relief and Economic Security (CARES) Act information reporting after the industry lodged several pointed complaints.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
The Senate is expected to vote today to end discussion on a continuing resolution that would keep the federal government funded at fiscal 2021 levels beyond Feb. 18. Read More
EMA follows FDA, which in December added its strictest warnings to the labels of a handful of JAK inhibitors, citing risk of serious health issues and death. Read More