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Regulatory Review Period Determined for Aklief

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Galdermas Aklief (trifarote...

FDA Approves New Insightec Exablate Neuro Indication

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FDA approves Insightecs Exablate Neuro for a third indication.

TecTraum Pro2Cool is Breakthrough Device

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FDA grants breakthrough device designation for TecTraums Pro2cool system to improve concussion outcomes.

FDA Oversight of Pfizer Covid Contractor Questioned

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A BMJ investigation says a Ventavia Research Group whistleblower informed FDA about multiple irregularities in the companys work t...

FDA Chief Scientist Hinton Leaves Agency

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FDA chief scientist and Public Health Service Commissioned Corps rear admiral Denise Hinton leaves the agency FDA to serve as depu...

CDER Moving to Electronic CPPs 12/3

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CDER says it is moving to electronic Certificates of Pharmaceutical Product as of 12/3.

FDA Fast Track for TransThera Drug

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FDA grants fast track designation to TransThera Sciences experimental Phase 2 cholangiocarcinoma drug.

10-item FDA-483 to Innoveix Pharmaceuticals

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An FDA inspection leads to a 10-item Form FDA-483 issued to Innoveix Pharmaceuticals that took issue with the firms GMPs for steri...

FDA Extends PDUFA Date for Janssen BLA

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FDA extends to 2/28/22 the PDUFA action date for a Janssen BLA for its cilta-cel multiple myeloma treatment.

9 QS Violations in CellEra Inspection

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FDA warns CellEra about multiple repeat Quality System violations in its as a specification developer and distributor of sterile w...