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FDA cites Nubratori Inc. for multiple manufacturing and contamination-control deficiencies following a December inspection of the ...[ Price : $8.95]
HHS Office of Inspector General issues new guidance clarifying when pharmaceutical manufacturers can sell prescription drugs direc...[ Price : $8.95]
Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firms petition seeking restrictions ...[ Price : $8.95]
The CDRH 2025 annual report says the Center authorized 124 novel medical devices last year, one of the highest numbers of authoriz...[ Price : $8.95]
FDA places clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the i...[ Price : $8.95]
A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regula...[ Price : $8.95]
FDA lifts a clinical hold on Intellia Therapeutics MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran for patients with her...[ Price : $8.95]
FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manu...