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Info on Safety Labeling Changes Guidance Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on a draft guidance on safety labeling changes to the Of...

Public Hearing on Potentially Threatening Pathogens

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Federal Register Notice; FDA plans a public hearing 12/18 to gain input on establishing a list of qualifying pathogens that have t...

FDA Inspection of Janssen Biotech Cites Remicade Manufacturing

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FDA cites Janssen Biotechs Malvern, PA facility for failing to adequately investigate unexplained discrepancies related to Remicad...

Cumberland Pharma Sues FDA Over Generic Acetadote

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Cumberland Pharmaceuticals files a lawsuit against FDA challenging the agencys decision to deny a citizen petition and approve Inn...

FDA Clears Quantel Ophthalmic Laser

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FDA clears a Quantel Medical 510(k) for its SupraScan 577 Laser, an ophthalmic laser system for treating a wide range of retinal d...

Panel to Discuss CoAxia NeuroFlo Catheter Device

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Federal Register Notice: FDAs Neurological Devices Panel will meet 12/10 to discuss the safety and effecitiveness of the CoAxia Ne...

Compliance Guide on OTC Bronchodilator Labeling

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Federal Register Notice: FDA releases a compliance guidance for small businesses on labeling for OTC bronchodilators.

AcelRx Pain System Meets Primary Endpoint

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AcelRx Pharmaceuticals reports that a Phase 3 study of its ARX-01 sublingual Sufentanil NanoTab PCA (patient-controlled analgesia)...

FDA Clears Semprus Bio Vascular Access Catheter

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FDA clears a Semprus BioSciences 510(k) for its vascular access catheter, Nylus Peripherally Inserted Central Catheter with Sempru...

FDA Panel Mixed on Heplisav Vaccine Effectiveness and Safety

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An FDA advisory committee votes 13 to 1 that a Dynavax Technologies BLA for Heplisav hepatitis B vaccine adequately demonstrated i...