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Jacobus Pharma Recalls 3 Ruzurgi Lots

[ Price : $8.95]

Jacobus Pharmaceutical recalls three lots of Ruzurgi (amifampridine) 10 mg tablets due to potential contamination with yeast, mold...

inTravent SoloPass Brain Imager Cleared

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FDA clears an inTravent Medical Partners 510(k) for the SoloPass system for aiding in the frontal placement of intra-ventricular c...

Fat Transfer Devices Moved to CBER Regulation

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Federal Register notice: FDA consolidates regulatory oversight responsibilities in CBER for certain devices, and accordingly fat t...

Guide on Gene Therapy Nonclinical Biodistribution

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FDA posts a draft International Conference for Harmonization guideline entitled Nonclinical Biodistribution Considerations For Gen...

Class 1 Recall of Ultrasound Gels

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FDA classifies as Class 1 an Eco-Med Pharmaceutical recall of all ultrasound gels and lotions manufactured by the company (XXX SUB...

BeiGen BLA for Anti-PD-1 Tislelizumab

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FDA accepts for review a BeiGene BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurre...

3 NDAs Withdrawn Over Missed Annual Reports

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Federal Register notice: FDA withdraws three NDAs because the application holders have repeatedly failed to file required annual r...

Retiring Vaccine Officials Reluctant on Boosters

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A Lancet article authored by two retiring senior FDA vaccine officials and other researchers argues against requiring Covid-19 boo...

Blood Products Panel to Hear Lab Research Updates

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Federal Register notice: FDA announces an 11/4 Blood Products Advisory Committee meeting that will hear CBER research updates.

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 9/10/2021.