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Class 1 Recall of Smiths CADD Infusion Sets

[ Price : $8.95]

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

Guide on Lasers for Surveying, Leveling and Aligning

[ Price : $8.95]

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

Class 1 Recall of Medtronic Leaky Catheters

[ Price : $8.95]

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

Guide on Acromegaly Drug Development

[ Price : $8.95]

FDA makes available a draft guidance entitled Acromegaly: Developing Drugs for Treatment.

Consent Decree Against LGM Pharma

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

FDA Extends Review of Argenx BLA

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

CDER/CBER Restarting In-Person Industry Meetings

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CDER and CBER say that beginning 2/13 they will restart limited in-person, face-to-face industry meetings.

Oracle Technology Guru Named FDA Digital Health Director

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Eleven-year Oracle veteran Troy Tazbaz joins FDA as Digital Health Center of Excellence director, replacing Bakul Patel who left t...

Info Collection Revision on PMA Submissions

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Federal Register notice: FDA seeks comments on an information collection revision entitled Premarket Approval of Medical Devices....

Panel to Discuss Non-Rx Naloxone Spray

[ Price : $8.95]

Federal Register notice: FDA announces a 3/20 joint advisory committee meeting to review an NDA for proposed nonprescription nasal...