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CoreLink 3D-printed Anterior Lumbar Device Cleared

[ Price : $8.95]

FDA clears a CoreLink Surgical 510(k) for the 3-D printed M3 Stand-Alone Anterior Lumbar System.

AbbVie sNDA Accepted for Imbruvica

[ Price : $8.95]

FDA accepts for priority review an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) in ...

Groups Praise FDA Expansion Cohorts Guidance

[ Price : $8.95]

Five stakeholders respond to an FDA draft guidance on use of expansion cohorts in some oncology trials.

FDA Cybersecurity MOU with Homeland Security Department

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FDA and the Department of Homeland Security sign a Memorandum of Understanding on medical device cybersecurity coordination.

FDA Looking at Mitochondrial Drugs and Cancer Cells: Spotlight

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A CDER Spotlight on Science describes how the Office of Pharmaceutical Quality is researching the effects of mitochondrial drugs o...

FDA Posts Lists of Molecular Targets for Pediatric Cancer

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Federal Register notice: FDAs Oncology Center of Excellence Pediatric Oncology Program has announced the creation of two lists of ...

Draft Guide on Hematologic Malignancies Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancies: Regulatory Considerations for Use...

Guide on Targeted Therapies

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Federal Register notice: FDA makes available a final guidance entitled Developing Targeted Therapies in Low-Frequency Molecular Su...

Clinical Investigator Violations Cited

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FDA warns California doctor Ignatius Godoy about violations in his role as clinical investigator in a pediatric flu vaccine study.

Regulatory Considerations for Dialysis Catheters

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CDRH participates in a Kidney Health Initiative workgroup to explain regulatory considerations for central venous catheters for he...