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FDA Green Light for Kidney Transplant Trial

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FDA gives Isotechnika Inc. permission to begin the first of two planned Phase 3 kidney transplant trials for its lead product cand...

Ranbaxy Under Scrutiny After Generic Lipitor Recall

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Ranbaxy recalls dozens of lots of generic Lipitor after detecting small glass particles in some batches, a move that is likely to ...

Deka Petition Seeks Stair Wheelchair Reclassification

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Deka Research and Development Corp. petitions FDA to reclassify stair-climbing wheelchairs from Class 3 to Class 2 devices.

FzioMed Appeals CDRH PMA Denial of Oxiplex/SP Gel

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FzioMed seeks dispute panel resolution of a CDRH decision to deny approval for its PMA for Oxiplex/SP Gel for use in back surgery.

New OGD Procedure for Grouped CMC Supplements

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CDER releases a new policy procedure for handling reviews of grouped chemistry, manufacturing and controls supplements.

FDA Rejects Petition Seeking Lindane Ban

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FDA rejects a petition submitted by Natural Resources Defense Council that sought the market withdrawal of products containing lin...

FDA Accepts MAP Pharma Resubmission for Migraine Drug

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FDA accepts for review a MAP Pharmaceuticals NDA resubmission for Levadex (dihydroergotamine) inhalation aerosol for treating migr...

Guidance on Artificial Pancreas Device Systems

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Federal Register Notice: FDA releases a guidance, The Content of Investigational Device Exemption (IDE) and Premarket Approval (PM...

FDA Orphan Status for Seattle Genetics Drug

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FDA grants an orphan drug designation to Seattle Genetics Adcetris (brentuximab vedotin) for treating mycosis fungoides.

FDA Orphan Status for OxiGene Leukemia Candidate

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FDA grants OxiGene an orphan drug designation for OXi4503 for treating acute myelogenous leukemia.