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FDA Releases 39-Page Lupin FDA-483

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DA releases a 39-page FDA-483 with 13 observations issued following a lengthy inspection at Lupins Somerset, NJ, drug manufacturin...

Janssen Accelerated Approval for Darzalex Faspro

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FDA grants accelerated approval to Janssen Biotechs Darzalex Faspro (daratumumab plus hyaluronidase) for combination use with bort...

Daiichi Sankyos Enhertu for Gastric Cancer

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FDA approves a Daiichi Sankyo BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) for certain adult patients with locally advanced o...

DePuy Synthes Robotic Knee System Cleared

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FDA clears a DePuy Synthes 510(k) for the Velys Robotic-Assisted Solution and its use with the Attune Total Knee System.

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Bodyhealth.

U.S. Stem Cell Defends Practices in Appeals Court

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U.S. Stem Cell tells an appeals court that its stromal vascular fraction procedure is not subject to FDA regulation under a 2001 F...

Omeros BLA for Stem Cell Transplant Complication

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FDA accepts for priority review an Omeros BLA for narsoplimab for treating hematopoietic stem cell transplant-associated thromboti...

FDA Gives PMA Approval for Seno Breast Cancer Diagnostic

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FDA gives PMA approval to Seno Medical Instruments Imagio diagnostic breast cancer imaging technology.

Info Collection on Drug Communications Supporting Data

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Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications...

Politics Cant Be Kept Out of FDA: Opinion

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Three University of Pennsylvania medical school health policy experts propose a way to keep necessary political involvement in FDA...