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FDA has released the form FDA-483 issued with 15 observations from an inspection at the Jubilant HollisterStier drug manufacturing...[ Price : $8.95]
FDA clears a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram,...[ Price : $8.95]
FDA says the Innovative Science and Technology Approaches for New Drugs pilot is transitioning into a permanent drug development t...[ Price : $8.95]
Politico reports that despite strong support from FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., Preside...[ Price : $8.95]
U.S. Senators Ted Budd (R-NC) and Martin Heinrich (D-NM) introduce a bipartisan amendment to FDAs fiscal year 2026 spending bill t...[ Price : $8.95]
FDA orders new mandatory safety labeling changes for all opioid analgesics, a move aimed at curbing long-term misuse of the produc...[ Price : $8.95]
FDA publishes a guidance explaining the process it uses to determine and qualify a MDUFA small business.[ Price : $8.95]
FDA grants Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma.