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Trevena Files NDA for Olinvo for Pain

[ Price : $8.95]

Trevena files an NDA for Olinvo (oliceridine injection) for treating pain.

Guide on CDER Dispute Resolution Above the Division Level

[ Price : $8.95]

FDA posts a final guidance on Formal Dispute Resolution: Sponsor Appeals Above the Division Level that provides recommendations fo...

Bayers Revex Not Withdrawn Due to Safety/Effectiveness

[ Price : $8.95]

Federal Register notice: FDA determines that Bayers Revex (nalmefene hydrochloride injection), which is indicated for reversing an...

Generic Drug Correspondence Guidance

[ Price : $8.95]

FDA releases a draft guidance incorporating GDUFA 2 revisions on generic drug development controlled correspondence.

FDA Clears IntraFuse Fibula Pin System

[ Price : $8.95]

FDA clears an IntraFuse 510(k) for its FlexThread Fibula Pin System that is intended to provide percutaneous fixation of distal fi...

FDA Looking at Opioid Packaging Changes: Gottlieb

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FDA commissioner Scott Gottlieb says the agency is very interested in exploring using new opioid packaging requirements to help re...

FDA Renews Patient Engagement Advisory Committee for 2 Years

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Federal Register notice: FDA announces the renewal of the Patient Engagement Advisory Committee for an additional two years.

Comments Sought on Radiopharmaceuticals Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension for Regulations for In Vivo Radiopharmaceutical...

Philips Consent Decree Posted

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FDA Webview posts the court-approved consent decree between FDA and Philips North America that prohibits manufacturing, processing...

Suggestions for Device Guidance Changes

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Three stakeholders suggest language changes for an FDA draft guidance on submitting a 510(k) for a change to an existing device.