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Zeiss Medical Gets Clearance for Intrabeam 700

[ Price : $8.95]

FDA clears a Zeiss Medical Technology 510(k) for its Intrabeam 700, a robotic-assisted platform to support intraoperative radiatio...

Generic Policy Shop Cuts will Hurt ANDAs: Post

[ Price : $8.95]

Hyman, Phelps & McNamara attorney Kurst Karst says recent staff cuts at FDA that eradicated the Office of Generic Drugs Division o...

Outlook Refiles BLA for Wet AMD Drug

[ Price : $8.95]

FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic for...

Coordinate HHS Drug Shortage Activities: GAO

[ Price : $8.95]

The Government Accountability Office says HHS should have some mechanism in place to coordinate the activities of various HHS agen...

FDA OKs Dropping Tryvio REMS

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FDA approves updated labeling for Idorsias blood pressure drug Tryvio after approving the elimination of a REMS requirement.

Raskin, Others Seek FDA Meeting on Cuts

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Members of Congress from Maryland, led by Rep. Jamie Raskin, ask to meet with FDA commissioner Martin Makary to discuss their conc...

Kessler Slams Dangerous FDA Cuts at Hearing

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Former FDA commissioner David Kessler tells a House hearing that recent FDA staff cuts will adversely affect the U.S.s public heal...

Device Approvals Slow to 10-Year Low: Report

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The Minneapolis Star Tribune says medical device companies are concerned that FDA layoffs have resulted in fewer device approvals ...

User Fee Programs are in Jeopardy: FDA Watchers

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FDA regulatory experts warn that the agencys user fee programs could be in jeopardy based on sweeping layoffs and political indiff...

Restrict 2 Opioid Indications: Petition

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Physician Douglas Smith petitions FDA to take 11 steps to curtail the use of the indications of opioid addiction and opioid use di...