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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...

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...

FDA OKs Opdivo/Yervoy in Colon Cancer

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FDA approves Bristol Myers Squibbs combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for treating certain adult and pedia...

Multiple Violations at EpiCare Acquisitions

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FDA warns Lawrenceville, NJ-based EpiCare Acquisitions about Quality System and other violations in its manufacturing of a family ...

Bausch Recalls Intraocular Lenses After Reports

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Bausch + Lomb recalls its enVista intraocular lenses after the company received reports of complications, which it says could not ...

Laboratory-Developed Test Decision Reviewed

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Six Sidley attorneys raise several practical questions arising from a Texas federal court decision finding that FDA does not have ...