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Regulatory Review Period Determined for Tremfya

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Federal Register notice: FDA determines the patent extension-related regulatory review period for Janssen Biotechs Tremfya (guselk...

Gil Debarred for 6 Years Over Healthcare Fraud

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Federal Register notice: FDA debars Isachi Gil for six years from providing services in any capacity to a person that has an appro...

FDA Proposes 2 Drug Communication Studies

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FDA solicits comments on two proposed CDER Office of Prescription Drug Promotion research projects.

FDA Looks to Technology Advances to Help Product Labeling

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FDA chief of staff Lauren Silvis says the agency is evolving to keep pace with technology advances, and one area it wants to focus...

CoreLink 3D-printed Anterior Lumbar Device Cleared

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

AbbVie sNDA Accepted for Imbruvica

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

Groups Praise FDA Expansion Cohorts Guidance

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Five stakeholders respond to an FDA draft guidance on use of expansion cohorts in some oncology trials.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