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Software Function Premarket Submission Guidance

[ Price : $8.95]

FDA publishes a draft guidance on recommended documentation for premarket submissions of medical device software functions.

FDA Evaluating Compounding MOU Court Action

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FDA says it is evaluating a DC federal court ruling remanding to the agency its memorandum of understanding with states on the int...

Adakveo Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Adakveo (crizanliz...

Dengvaxia Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofis Dengvaxia (dengue t...

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.