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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 ...

Support, Suggestions for FDA Regulatory AI Guidance

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Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for a...

Zeiss Medical Gets Clearance for Intrabeam 700

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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

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

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...

ZyVersa Touts Approval Path for Kidney Disorder Drug

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ZyVersa Therapeutics says a new regulatory development could significantly shorten the path to approval for treatments targeting f...

FDA Like Flat Earthers Taking Over NASA: Woodcock

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Three former FDAers warn of a slow-moving catastrophe coming for the agency as it loses staff and resources under leaders who have...