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Regulatory Review Period for Genentechs Ocrevus

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Genentechs Ocrevus ...

Experts Divided Over Drug Price Ad Proposal

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A Bloomberg Law online post explores differing views on the legality and effectiveness of an HHS proposal to require drug companie...

Draft Guide on Cybersecurity for Medical Devices

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Federal Register notice: FDA has made available a draft guidance entitled Content of Premarket Submissions for Management of Cyber...

Quik Program Explained in Webinar

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A CDRH Webinar reviews the 510(k) Quik pilot program requirements and operation.

Study of Accelerated Approval Disclosures

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Federal Register notice: FDA seeks comments on a new proposed research study entitled Experimental Study of an Accelerated Approva...

Study on Disease Awareness/DTC Ad Impacts

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Federal Register notice: FDA seeks public comments on a proposed research study entitled, Disease Awareness and Prescription Drug ...

Class 2 for Upper Limb Tremor Stimulator

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Federal Register notice: FDA classifies the external upper limb tremor stimulator into Class 2 (special controls).

Teva Sues FDA Over Generic Restasis Exclusivity

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Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.

Walmarts Yiannis Named FDA Deputy Commissioner

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FDA commissioner Scott Gottlieb announces the appointment of Walmart executive Frank Yiannis as deputy commissioner for food polic...

Stakeholders Want More Device Accessories Reclassified

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Stakeholders ask for changes to an FDA list of medical device accessories proposed for down-classification to Class 1.