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Human Drugs

Generic Policy Shop Cuts will Hurt ANDAs: Post

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

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Biologics

Outlook Refiles BLA for Wet AMD Drug

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

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Human Drugs

Coordinate HHS Drug Shortage Activities: GAO

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

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Human Drugs

FDA OKs Dropping Tryvio REMS

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

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FDA General

Raskin, Others Seek FDA Meeting on Cuts

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

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FDA General

Kessler Slams Dangerous FDA Cuts at Hearing

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

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Medical Devices

Device Approvals Slow to 10-Year Low: Report

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

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FDA General

User Fee Programs are in Jeopardy: FDA Watchers

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

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Human Drugs

Restrict 2 Opioid Indications: Petition

Physician Douglas Smith petitions FDA to take 11 steps to curtail the use of the indications of opioid addiction and opioid use disorder in drug manuf...

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Human Drugs

ZyVersa Touts Approval Path for Kidney Disorder Drug

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