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Class 1 Recall of Puritan Bennett Ventilators

[ Price : $8.95]

Nellcor Puritan Bennett begins a Class 1 recall of its Puritan Bennett 980 Ventilator System due to a software error.

CDER Posts MAPP on Critical Path Innovation Meetings

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CDER posts a new manual of policies and procedures document for Critical Path Innovation Meetings.

Repros, FDA Meet on Andoxal NDA

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Repros Therapeutics reports a meeting with FDA resulted in no additional study requirements to date for its anticipated low-testos...

Legacy 510(k) Devices Need Cybersecurity Risk Assessments: CDRH

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CDRH policy analyst Abiy Desta says legacy 510(k)-cleared devices that are being modified and require a new 510(k) submission will...

FDA Revokes Ranbaxy Tentative Approvals

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FDA revokes tentative approval decisions granted to Ranbaxy Laboratories for generic copies of AstraZenecas heartburn drug Nexium ...

FDA Clears Cutera Laser for Tattoo Removal

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FDA clears a Cutera 510(k) for its Enlighten laser system for tattoo removal.

FDA Panel Rejects Novartis Multiple Myeloma Drug

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FDAs Oncologic Drugs Advisory Committee votes 5 to 2 not to recommend approval for Novartis panobinostat, a pan-deacetylase (pan-D...

FDA Approves New Cyramza Indication

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FDA approves a new indication for Lillys Cyramza to be used with paclitaxel to treat metastatic gastric or gastroeshopageal juncti...

What's Next for FDA in the New Congress

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FDA Webview examines how the mid-term elections have shaped Congress and whats in store for FDA.

Comments Sought on Appeals Above the Division Level at CVM

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Federal Register Notice: FDA invites comments on the information collection requirements for appeals of science-based decision abo...