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The International Council for Harmonization says its electronic common technical document working group has issued updated support...[ Price : $8.95]
Arrowhead Pharmaceuticals agrees to acquire an FDA Rare Pediatric Disease Priority Review Voucher from an undisclosed third party ...[ Price : $8.95]
Four stakeholders praise an FDA draft guidance on streamlining some oncology nonclinical safety studies and recommend improvements...[ Price : $8.95]
FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance o...[ Price : $8.95]
FDA issues an updated final guidance entitled Applying Human Factors and Usability Engineering to Medical Devices.[ Price : $8.95]
FDA grants Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for treating adult patients with advanced ...[ Price : $8.95]
Sandoz reaches agreements totaling about $479 million to resolve most of its remaining exposure in long-running U.S. litigation al...[ Price : $8.95]
FDA regulatory experts support the agency's new "Operation Trialblazer" initiative as an important step toward accelerating drug d...