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Biologics

CBER Tissues/Advanced Therapies Director Bryan Retiring

After more than 22 years at FDA, CBER Office of Tissues and Advanced Therapies director Wilson Bryan announces he is retiring in March.

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FDA General

Califf Proposes Transformation of Foods Program, ORA

FDA commissioner Robert Califf announces a new transformative vision for the agencys human foods program and the Office of Regulatory Affairs that add...

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Federal Register

2 EUAs Granted for Mpox Diagnostics

Federal Register notice: FDA announces the issuance of two Emergency Use Authorizations for diagnostic devices intended for use during the ongoing Mon...

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Federal Register

Optical Camera Software for Respiratory Measurements

Federal Register notice: FDA classifies software for optical camera-based measurements of pulse rate, heart rate, breathing rate, and/or respiratory r...

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Medical Devices

Class 1 Recall of Smiths CADD Infusion Sets

FDA classifies as Class 1 a Smiths Medical recall associated with a 12/2022 company-issued urgent medical device correction letter identifying two pot...

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Medical Devices

Guide on Lasers for Surveying, Leveling and Aligning

FDA posts a final guidance entitled Surveying, Leveling, and Alignment Laser Products that addresses radiation safety product performance standards.

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Medical Devices

Class 1 Recall of Medtronic Leaky Catheters

FDA classifies as Class 1 a Medtronic recall of its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking conditi...

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Human Drugs

Guide on Acromegaly Drug Development

FDA makes available a draft guidance entitled Acromegaly: Developing Drugs for Treatment.

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Human Drugs

Consent Decree Against LGM Pharma

The U.S. District Court for Southern Florida enters a consent decree of permanent injunction against LGM Pharma and two of the company's executives.

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Human Drugs

FDA Extends Review of Argenx BLA

FDA extends by three months its review of an Argenx BLA for subcutaneous efgartigimod for treating adult patients with generalized myasthenia gravis.