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Medical Devices

Anumana Pulmonary Hypertension AI Tool Wins Clearance

FDA clears an Anumana 510(k) for an artificial intelligencebased tool designed to detect early signs of pulmonary hypertension.

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Biologics

FDA Flags Quality System Gaps at CSL Behring Site

FDA posts a Form 483 that identifies deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring GmbH in Marburg, Ge...

Human Drugs

FDA 483 Guidance Raises Compliance Bar: Cooley

FDAs new draft guidance outlining expectations for how drug manufacturers should respond to Form FDA 483 observations following inspections of current...

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FDA General

FDA Commissioner Outlines Ambitious Vision for Breakthrough Treatments

FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see transformative treatm...

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Human Drugs

October Deadline for New Adverse Event Reporting Standard

FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for submitting postmarke...

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Human Drugs

Context Therapeutics Ovarian Cancer Drug Wins Fast Track

FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovarian cancer.

FDA General

HHS Weighs Reversal of FDA Peptide Restrictions Despite Safety Concerns

HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has spa...

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Medical Devices

FDA Denies CAD/CADt Device 510(k) Exemption Petition

FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/or diagnosis devices...

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Human Drugs

Bipartisan Senators Urge FDA to Pre-Screen Certain Drug Ads

Two bipartisan senators press FDA to take a more proactive role in policing prescription drug advertising, citing a surge in misleading direct-to-cons...

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Biologics

FDA Accepts Ultragenyx Resubmission for Gene Therapy

Ultragenyx Pharmaceutical refiles a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A....